Food and Drug Administration, HHS Pt. 520

PART 520—ORAL DOSAGE FORM 520.420 Chlorothiazide tablets and boluses. 520.434 Chlorphenesin carbamate tablets. NEW ANIMAL DRUGS 520.441 Chlortetracycline powder. 520.443 Chlortetracycline tablets and Sec. boluses. 520.23 Acepromazine. 520.445 Chlortetracycline and 520.28 Acetazolamide. sulfamethazine powder. 520.38 Albendazole oral dosage forms. 520.446 Clindamycin capsules and tablets. 520.38a Albendazole suspension. 520.447 Clindamycin solution. 520.38b Albendazole paste. 520.452 Clenbuterol syrup. 520.43 Afoxolaner. 520.455 Clomipramine tablets. 520.48 Altrenogest. 520.462 Clorsulon drench. 520.62 Aminopentamide. 520.522 Cyclosporine. 520.82 Aminopropazine oral dosage forms. 520.530 Cythioate oral liquid. 520.82a Aminopropazine. 520.531 Cythioate tablets. 520.82b Aminopropazine and neomycin. 520.534 Decoquinate. 520.88 Amoxicillin oral dosage forms. 520.538 Deracoxib. 520.88a Amoxicillin trihydrate film-coated 520.540 Dexamethasone oral dosage forms. tablets. 520.540a Dexamethasone powder. 520.88b Amoxicillin trihydrate for oral sus- 520.540b Dexamethasone tablets and pension. boluses. 520.88c Amoxicillin trihydrate oral suspen- 520.540c Dexamethasone chewable tablets. sion. 520.563 Dexamethasone chewable tablets. 520.88d Amoxicillin trihydrate soluble pow- 520.580 Dichlorophene and toluene. der. 520.581 Dichlorophene tablets. 520.88e Amoxicillin trihydrate boluses. 520.600 Dichlorvos. 520.88f Amoxicillin trihydrate tablets. 520.606 Diclazuril. 520.88g Amoxicillin trihydrate and 520.608 Dicloxacillin. clavulanate potassium film-coated tab- 520.620 Diethylcarbamazine oral dosage lets. forms. 520.88h Amoxicillin trihydrate and 520.622 Diethylcarbamazine citrate oral dos- clavulanate potassium for oral suspen- age forms. sion. 520.622a Diethylcarbamazine citrate tablets. 520.90 Ampicillin oral dosage forms. 520.622b Diethylcarbamazine citrate syrup. 520.90a [Reserved] 520.622c Diethylcarbamazine citrate chew- 520.90b Ampicillin tablets. able tablets. 520.90c Ampicillin capsules. 520.623 Diethylcarbamazine and 520.90d Ampicillin for oral suspension. oxibendazole chewable tablets. 520.90e Ampicillin for soluble powder. 520.645 Difloxacin. 520.90f Ampicillin boluses. 520.666 Dirlotapide. 520.100 Amprolium. 520.763 Dithiazanine oral dosage forms. 520.110 Apramycin sulfate soluble powder. 520.763a Dithiazanine tablets. 520.154 Bacitracin oral dosage forms. 520.763b Dithiazanine powder. 520.154a Bacitracin methylenedisalicylate. 520.763c Dithiazanine iodide and piperazine 520.154b Bacitracin methylenedisalicylate citrate suspension. and streptomycin sulfate powder. 520.766 Domperidone. 520.154c Bacitracin zinc soluble powder. 520.784 Doxylamine. 520.222 Bunamidine hydrochloride. 520.804 Enalapril. 520.246 Butorphanol tablets. 520.812 Enrofloxacin. 520.260 n-Butyl chloride. 520.816 Epsiprantel. 520.284 Cambendazole oral dosage forms. 520.823 Erythromycin. 520.284a Cambendazole suspension. 520.852 Estriol. 520.284b Cambendazole pellets. 520.863 Ethylisobutrazine. 520.284c Cambendazole paste. 520.870 Etodolac. 520.292 Capromorelin. 520.903 Febantel oral dosage forms. 520.301 Caramiphen ethanedisulfonate and 520.903a Febantel paste. ammonium chloride tablets. 520.903b Febantel suspension. 520.302 Carnidazole tablets. 520.903c [Reserved] 520.304 Carprofen. 520.903d Febantel and praziquantel paste. 520.314 Cefadroxil. 520.903e Febantel tablets. 520.370 Cefpodoxime tablets. 520.905 Fenbendazole oral dosage forms. 520.376 Cephalexin. 520.905a Fenbendazole suspension. 520.390 Chloramphenicol oral dosage forms. 520.905b Fenbendazole granules. 520.390a Chloramphenicol tablets. 520.905c Fenbendazole paste. 520.390b Chloramphenicol capsules. 520.905d Fenbendazole powder. 520.390c Chloramphenicol palmitate oral 520.905e Fenbendazole blocks. suspension. 520.928 Firocoxib tablets.

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520.930 Firocoxib paste. 520.1331 Meclofenamic acid tablets. 520.955 Florfenicol. 520.1341 Megestrol. 520.960 Flumethasone. 520.1367 Meloxicam. 520.970 Flunixin. 520.1372 Methimazole. 520.980 Fluoxetine. 520.1380 Methocarbamol. 520.998 Fluralaner. 520.1408 Methylprednisolone. 520.1010 Furosemide. 520.1409 Methylprednisolone and aspirin. 520.1044 Gentamicin sulfate oral dosage 520.1422 Metoserpate hydrochloride. forms. 520.1430 Mibolerone. 520.1044a Gentamicin sulfate oral solution. 520.1441 Milbemycin oxime. 520.1044b Gentamicin sulfate pig pump oral 520.1443 Milbemycin oxime and lufenuron. solution. 520.1445 Milbemycin oxime and 520.1044c Gentamicin sulfate powder. praziquantel. 520.1060 Glucose and glycine. 520.1447 Milbemycin oxime, lufenuron, and 520.1084 Grapiprant. praziquantel tablets. 520.1100 Griseofulvin. 520.1450 Morantel tartrate oral dosage 520.1120 Haloxon oral dosage forms. forms. 520.1120a Haloxon drench. 520.1450a Morantel tartrate bolus. 520.1120b Haloxon boluses. 520.1450b Morantel tartrate cartridge. 520.1130 Hetacillin. 520.1450c Morantel tartrate sustained-re- 520.1156 Imidacloprid. lease trilaminate cylinder/sheet. 520.1157 Iodinated casein. 520.1451 Moxidectin tablets. 520.1158 Iodochlorhydroxyquin. 520.1452 Moxidectin gel. 520.1182 Iron dextran suspension. 520.1453 Moxidectin and praziquantel gel. 520.1189 Itraconazole. 520.1454 Moxidectin solution. 520.1192 Ivermectin paste. 520.1468 Naproxen. 520.1193 Ivermectin tablets and chewables. 520.1484 Neomycin. 520.1194 Ivermectin meal. 520.1510 Nitenpyram. 520.1195 Ivermectin liquid. 520.1604 Oclacitinib. 520.1196 Ivermectin and pyrantel tablets. 520.1615 Omeprazole. 520.1197 Ivermectin sustained-release bolus. 520.1616 Orbifloxacin tablets.. 520.1198 Ivermectin and praziquantel paste. 520.1618 Orbifloxacin suspension. 520.1199 Ivermectin, pyrantel, and 520.1628 Oxfendazole powder and pellets. praziquantel tablets. 520.1629 Oxfendazole paste. 520.1200 Ivermectin, fenbendazole, and 520.1630 Oxfendazole suspension. praziquantel tablets. 520.1631 Oxfendazole and trichlorfon paste. 520.1204 Kanamycin, bismuth subcarbonate, 520.1638 Oxibendazole. activated attapulgite. 520.1660 Oxytetracycline. 520.1242 Levamisole. 520.1660a Oxytetracycline and carbomycin. 520.1242a Levamisole powder. 520.1660b Oxytetracycline hydrochloride 520.1242b Levamisole boluses or oblets. capsules. 520.1242c Levamisole and piperazine. 520.1660c Oxytetracycline hydrochloride 520.1242d Levamisole resinate. tablets/boluses. 520.1242e Levamisole hydrochloride effer- 520.1660d Oxytetracycline powder. vescent tablets. 520.1696 Penicillin. 520.1242f Levamisole gel. 520.1696a [Reserved] 520.1242g Levamisole resinate and famphur 520.1696b Penicillin G powder. paste. 520.1696c Penicillin V powder. 520.1248 Levothyroxine. 520.1696d Penicillin V tablets. 520.1263 Lincomycin. 520.1705 Pergolide. 520.1263a Lincomycin tablets and syrup. 520.1720 Phenylbutazone oral dosage forms. 520.1263b [Reserved] 520.1720a Phenylbutazone tablets and 520.1263c Lincomycin powder. boluses. 520.1265 Lincomycin and spectinomycin 520.1720b Phenylbutazone granules. powder. 520.1720c Phenylbutazone paste. 520.1284 Liothyronine. 520.1720d Phenylbutazone gel. 520.1288 Lufenuron tablets. 520.1720e Phenylbutazone powder. 520.1289 Lufenuron suspension. 520.1760 Phenylpropanolamine. 520.1310 Marbofloxacin. 520.1780 Pimobendan. 520.1315 Maropitant. 520.1802 Piperazine-carbon disulfide complex 520.1320 Mebendazole. oral dosage forms. 520.1326 Mebendazole and trichlorfon oral 520.1802a Piperazine-carbon disulfide com- dosage forms. plex suspension. 520.1326a Mebendazole and trichlorfon pow- 520.1802b Piperazine-carbon disulfide com- der. plex boluses. 520.1326b Mebendazole and trichlorfon paste. 520.1802c Piperazine-carbon disulfide com- 520.1330 Meclofenamic acid granules. plex with phenothiazine suspension.

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520.1803 Piperazine citrate capsules. 520.2260c Sulfamethazine sustained-release 520.1804 Piperazine phosphate capsules. tablets. 520.1805 Piperazine phosphate with thenium 520.2261 Sulfamethazine sodium oral dosage closylate tablets. forms. 520.1806 Piperazine suspension. 520.2261a Sulfamethazine solution. 520.1807 Piperazine. 520.2261b Sulfamethazine powder. 520.1840 Poloxalene. 520.2280 Sulfamethizole and methenamine. 520.1846 Polyoxyethylene (23) lauryl ether 520.2325 Sulfaquinoxaline oral dosage forms. blocks. 520.2325a Sulfaquinoxaline powder and solu- 520.1855 Ponazuril. tion. 520.1860 Pradofloxacin. 520.2325b Sulfaquinoxaline drench. 520.1870 Praziquantel tablets. 520.2330 Sulfisoxazole tablets. 520.1871 Praziquantel and pyrantel. 520.2340 Tepoxalin. 520.1872 Praziquantel, pyrantel pamoate, 520.2345 Tetracycline. and febantel tablets. 520.2345a Tetracycline capsules. 520.1880 Prednisolone. 520.2345b Tetracycline tablets. 520.1900 Primidone. 520.2345c Tetracycline boluses. 520.1920 Prochlorperazine and isopropamide. 520.2345d Tetracycline powder. 520.1921 Prochlorperazine, isopropamide, 520.2345e Tetracycline solution. and neomycin. 520.2345f Tetracycline phosphate complex 520.1962 Promazine. and sodium novobiocin capsules. 520.2345g Tetracycline hydrochloride and so- 520.2002 Propiopromazine. dium novobiocin tablets. 520.2041 Pyrantel pamoate chewable tablets. 520.2345h Tetracycline hydrochloride, so- 520.2042 Pyrantel pamoate tablets. dium novobiocin, and prednisolone tab- 520.2043 Pyrantel pamoate suspension. lets. 520.2044 Pyrantel pamoate paste. 520.2362 Thenium closylate. 520.2045 Pyrantel tartrate powder. 520.2380 Thiabendazole oral dosage forms. 520.2046 Pyrantel tartrate pellets. 520.2380a Thiabendazole top dressing and 520.2075 Robenacoxib. mineral protein block. 520.2086 Sarolaner. 520.2380b Thiabendazole drench or paste. 520.2098 Selegiline. 520.2380c Thiabendazole bolus. 520.2100 Selenium and vitamin E. 520.2380d Thiabendazole and piperazine cit- 520.2123 Spectinomycin oral dosage forms. rate. 520.2123a Spectinomycin tablets. 520.2380e Thiabendazole and trichlorfon. 520.2123b Spectinomycin powder. 520.2380f Thiabendazole and piperazine phos- 520.2123c Spectinomycin solution. phate. 520.2130 Spinosad. 520.2455 Tiamulin. 520.2134 Spinosad and milbemycin. 520.2471 Tilmicosin. 520.2150 Stanozolol. 520.2473 Tioxidazole oral dosage forms. 520.2158 Streptomycin. 520.2473a Tioxidazole granules. 520.2170 Sulfabromomethazine. 520.2473b Tioxidazole paste. 520.2184 Sulfachloropyrazine. 520.2475 Toceranib. 520.2200 Sulfachlorpyridazine. 520.2481 Triamcinolone acetonide tablets. 520.2215 Sulfadiazine/pyrimethamine sus- 520.2482 Triamcinolone acetonide oral pow- pension. der. 520.2218 Sulfamerazine, sulfamethazine, and 520.2483 Triamcinolone. sulfaquinoxaline powder. 520.2520 Trichlorfon oral dosage forms. 520.2220 Sulfadimethoxine oral dosage 520.2520a Trichlorfon and atropine. forms. 520.2520b Trichlorofon boluses. 520.2220a Sulfadimethoxine oral solution 520.2520c Trichlorofon granules. and soluble powder. 520.2520d Trichlorfon, phenothiazine, and pi- 520.2220b Sulfadimethoxine suspension. perazine dihydrochloride powder. 520.2220c Sulfadimethoxine tablet. 520.2582 Triflupromazine. 520.2220d Sulfadimethoxine bolus. 520.2598 Trilostane. 520.2220e Sulfadimethoxine extended-release 520.2604 Trimeprazine and prednisolone tab- bolus. lets. 520.2220f Sulfadimethoxine and ormetoprim 520.2605 Trimeprazine and prednisolone cap- tablet. sules. 520.2240 Sulfaethoxypyridazine. 520.2610 Trimethoprim and sulfadiazine tab- 520.2240a Sulfaethoxypyridazine solution. lets. 520.2240b Sulfaethoxypyridazine tablets. 520.2611 Trimethoprim and sulfadiazine 520.2260 Sulfamethazine oral dosage forms. paste. 520.2260a Sulfamethazine oblet, tablet, and 520.2612 Trimethoprim and sulfadiazine sus- bolus. pension. 520.2260b Sulfamethazine sustained-release 520.2613 Trimethoprim and sulfadiazine boluses. powder.

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520.2640 Tylosin. (b) Sponsor. See No. 054771 in § 510.600 520.2645 Tylvalosin. of this chapter. AUTHORITY: 21 U.S.C. 360b. (c) Related tolerances. See § 556.34 of this chapter. SOURCE: 40 FR 13838, Mar. 27, 1975, unless otherwise noted. (d) Special considerations. See § 500.25 of this chapter. § 520.23 Acepromazine. (e) Conditions of use—(1) Cattle. Ad- (a) Specifications. Each tablet con- minister 11.36 percent suspension: tains 5, 10, or 25 milligrams (mg) (i) Amount. 4.54 mg/pound (lb) body acepromazine maleate. weight (10 mg/kilogram (kg)) as a sin- (b) Sponsors. See No. 000010 in gle oral dose using dosing gun or dos- § 510.600(c) of this chapter. ing syringe. (c) Conditions of use—(1) Dogs—(i) (ii) Indications for use. For removal Amount. 0.25 to 1.0 mg per pound (/lb) and control of adult liver flukes body weight orally. (Fasciola hepatica); heads and segments (ii) Indications for use. As an aid in of tapeworms (Moniezia benedeni and M. tranquilization and as a preanesthetic expansa); adult and 4th stage larvae of agent. stomach worms (brown stomach worms (iii) Limitations. Federal law restricts including 4th stage inhibited larvae this drug to use by or on the order of a (Ostertagia ostertagi), barberpole worm licensed veterinarian. (Haemonchus contortus and H. placei), (2) Cats—(i) Amount. 0.5 to 1.0 mg/lb small stomach worm (Trichostrongylus body weight orally. axei)); adult and 4th stage larvae of in- (ii) Indications for use. As a tranquil- testinal worms (thread-necked intes- izer. tinal worm (Nematodirus spathiger and (iii) Limitations. Federal law restricts N. helvetianus), small intestinal worm this drug to use by or on the order of a (Cooperia punctata and C. oncophora)); licensed veterinarian. adult stages of intestinal worms (hookworm (Bunostomum phlebotomum), [75 FR 10165, Mar. 5, 2010] bankrupt worm (Trichostrongylus colubriformis), nodular worm § 520.28 Acetazolamide. (Oesophagostomum radiatum)); adult and (a) Specifications. A powder con- 4th stage larvae of lungworms taining acetazolamide sodium, USP (Dictyocaulus viviparus). equivalent to 25 percent acetazolamide (iii) Limitations. Do not slaughter activity. within 27 days of last treatment. Do (b) Sponsor. See No. 054771 in not use in female dairy cattle of breed- § 510.600(c) of this chapter. ing age: Do not administer to female (c) Conditions of use in dogs—(1) cattle during first 45 days of pregnancy Amount. Administer orally at a dosage or for 45 days after removal of bulls. of 5 to 15 milligrams per pound of body (2) Sheep. Administer 4.45 or 11.36 per- weight daily. cent suspension: (2) Indications for use. As an aid in the (i) Amount. 3.4 mg/lb body weight (7.5 treatment of mild congestive heart mg/kg) as a single oral dose using dos- failure and for rapid reduction of intra- ing gun or dosing syringe. ocular pressure. (ii) Indications for use. For removal (3) Limitations. Federal law restricts and control of adult liver flukes this drug to use by or on the order of a (Fasciola hepatica and Fascioloides licensed veterinarian. magna); heads and segments of common [79 FR 28816, May 20, 2014] tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma § 520.38 Albendazole oral dosage actinioides); adult and fourth stage lar- forms. vae of stomach worms (brown stomach worm (Ostertagia circumcinta and § 520.38a Albendazole suspension. Marshallagia marshalli), barberpole (a) Specifications. Each milliliter of worm (Haemonchus contortus), small suspension contains 45.5 milligrams stomach worm (Trichostrongylus axei)); (mg) (4.55 percent) or 113.6 mg (11.36 adult and fourth stage larvae of intes- percent) albendazole. tinal worms (thread-necked intestinal

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worm (Nematodirus spathiger and N. bankrupt worm (Trichostrongylus filicollis), Cooper’s worm (Cooperia colubriformis), nodular worm oncophora), bankrupt worm (Oesophagostomum radiatum)); adult and (Trichostrongylus colubriformis), nodular 4th stage larvae of lungworms worm (Oesophagostomum columbianum), (Dictyocaulus viviparus). and large-mouth bowel worm (Chabertia (3) Limitations. Administer as a single ovina)); adult and larval stages of oral dose. Do not slaughter within 27 lungworms (Dictyocaulus filaria). days of last treatment. Do not use in (iii) Limitations. Do not slaughter female dairy cattle of breeding age. Do within 7 days of last treatment. Do not not administer to female cattle during administer to ewes during first 30 days first 45 days of pregnancy or for 45 days of pregnancy or for 30 days after re- after removal of bulls. Consult your moval of rams. veterinarian for assistance in the diag- (3) Goats. Administer 11.36 percent nosis, treatment, and control of para- suspension: sitism. (i) Amount. 4.54 mg/lb body weight (10 [54 FR 51385, Dec. 15, 1989, as amended at 56 mg/kg) as a single oral dose using dos- FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, ing gun or dosing syringe. 1995. Redesignated at 78 FR 66264, Nov. 5, (ii) Indications for use. For the treat- 2013, as amended at 79 FR 28816, May 20, 2014] ment of adult liver flukes (Fasciola he- patica) in nonlactating goats. § 520.43 Afoxolaner. (iii) Limitations. Do not slaughter (a) Specifications. Each chewable tab- within 7 days of last treatment. Do not let contains 11.3, 28.3, 68, or 136 milli- administer to does during the first 30 grams (mg) afoxolaner. days of pregnancy or for 30 days after (b) Sponsor. See No. 050604 in removal of bucks. § 510.600(c) of this chapter. [73 FR 11027, Feb. 29, 2008. Redesignated at 78 (c) Conditions of use—(1) Amount. Ad- FR 66264, Nov. 5, 2013, as amended at 79 FR minister orally once a month at a min- 28816, May 20, 2014] imum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)). § 520.38b Albendazole paste. (2) Indications for use. Kills adult (a) Specifications. The product con- fleas; for the treatment and prevention tains 30 percent albendazole. of flea infestations (Ctenocephalides (b) Sponsor. See No. 054771 in felis); for the treatment and control of § 510.600(c) of this chapter. black-legged tick (Ixodes scapularis), (c) Related tolerances. See § 556.34 of American dog tick (Dermacentor this chapter. variabilis), lone star tick (Amblyomma (d) Conditions of use in cattle—(1) americanum), and brown dog tick Amount. Equivalent to 4.54 milligrams (Rhipicephalus sanguineus) infestations per 1 pound of body weight (10 milli- in dogs and puppies 8 weeks of age and grams per kilogram). older, weighing 4 lb of body weight or (2) Indications for use. For removal greater, for 1 month. and control of the following internal (3) Limitations. Federal law restricts parasites of cattle: adult liver flukes this drug to use by or on the order of a (Fasciola hepatica); heads and segments licensed veterinarian. of tapeworms (Moniezia benedeni, M. [78 FR 66264, Nov. 5, 2013, as amended at 79 expansa); adult and 4th stage larvae of FR 37619, July 2, 2014; 80 FR 18775, Apr. 8, stomach worms (brown stomach worms 2015] including 4th stage inhibited larvae (Ostertagia ostertagi); barberpole worm § 520.48 Altrenogest. (Haemonchus contortus, H. placei); small (a) Specifications. Each milliliter stomach worm (Trichostrongylus axei)); (mL) of solution contains 2.2 milli- adult and 4th stages larvae of intes- grams (mg) altrenogest. tinal worms (thread-necked intestinal (b) Sponsors. See Nos. 000061 and worm (Nematodirus spathiger, N. 013744 in § 510.600(c) of this chapter. helvetianus); small intestinal worm (c) Tolerances. See § 556.36 of this (Cooperia punctata and C. oncophora)); chapter. adult stages of intestinal worms (d) Conditions of use—(1) Horses—(i) (hookworm (Bunostomum phlebotmum); Amount. 1.0 mL per 110 pounds body

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weight (0.044 mg/kg) daily for 15 con- § 520.82 Aminopropazine oral dosage secutive days. forms. (ii) Indications for use. For suppres- sion of estrus in mares. § 520.82a Aminopropazine. (iii) Limitations. Do not use in horses (a) Specifications. Each tablet con- intended for human consumption. Fed- tains aminopropazine fumarate equiva- eral law restricts this drug to use by or lent to 25 percent aminopropazine base. on the order of a licensed veterinarian. (b) Sponsor. See No. 000061 in (2) Swine—(i) Amount. Administer 6.8 § 510.600(c) of this chapter. mL (15 mg altrenogest) per gilt once (c) Conditions of use in dogs and cats— daily for 14 consecutive days by top- (1) Amount. Administer orally at a dos- dressing on a portion of each gilt’s age of 1 to 2 milligrams per pound of daily feed. body weight, repeated every 12 hours as (ii) Indications for use. For synchroni- indicated. zation of estrus in sexually mature (2) Indications for use. For reducing gilts that have had at least one estrous excessive smooth muscle contractions, cycle. such as occur in urethral spasms asso- (iii) Limitations. Do not use in gilts ciated with urolithiasis. having a previous or current history of (3) Limitations. Federal law restricts uterine inflammation (i.e., acute, this drug to use by or on the order of a subacute or chronic endometritis). licensed veterinarian. Gilts must not be slaughtered for [79 FR 28816, May 20, 2014] human consumption for 21 days after the last treatment. § 520.82b Aminopropazine and neomy- cin. [66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, (a) Specifications. Each tablet con- 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, tains aminopropazine fumarate equiva- May 31, 2012; 80 FR 34278, June 16, 2015] lent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 § 520.62 Aminopentamide. milligrams (mg) of neomycin base. (a) Specifications. Each tablet con- (b) Sponsor. See No. 000061 in tains 0.2 milligram (mg) § 510.600(c) of this chapter. aminopentamide hydrogen sulphate. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 054771 in Amount. Administer orally at a dosage § 510.600(c) of this chapter. of 1 to 2 mg per pound of body weight, (c) Conditions of use in dogs and cats— repeated every 12 hours as indicated. (2) Indications for use. For control of (1) Amount. Administer orally every 8 bacterial diarrhea caused by organisms to 12 hours as follows: For animals susceptible to neomycin and to reduce weighing up to 10 pounds (lbs): 0.1 mg; smooth muscle contractions. for animals weighing 11 to 20 lbs: 0.2 (3) Limitations. Federal law restricts mg; for animals weighing 21 to 50 lbs: this drug to use by or on the order of a 0.3 mg; for animals weighing 51 to 100 licensed veterinarian. lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be gradu- [79 FR 28816, May 20, 2014] ally increased up to a maximum of five times the suggested dosage. Oral ad- § 520.88 Amoxicillin oral dosage forms. ministration of tablets may be pre- § 520.88a Amoxicillin trihydrate film- ceded by subcutaneous or coated tablets. intramuscular use of the injectable form of the drug. (a) Specifications. Each tablet con- (2) Indications for use. For the treat- tains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams ment of vomiting and/or diarrhea, nau- (mg) amoxicillin. sea, acute abdominal visceral spasm, (b) Sponsor. See No. 054771 in pylorospasm, or hypertrophic gastritis. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i) this drug to use by or on the order of a Amount. Administer orally 5 mg per licensed veterinarian. pound (/lb) of body weight, twice a day [79 FR 28816, May 20, 2014] for 5 to 7 days.

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(ii) Indications for use. Treatment of gastroenteritis) caused by S. aureus, infections of the respiratory tract (ton- Streptococcus spp., E. coli, and P. sillitis, tracheobronchitis), genito- mirabilis; bacterial dermatitis caused urinary tract (cystitis), gastro- by S. aureus, Streptococcus spp., and P. intestinal tract (bacterial mirabilis; and soft tissues (abscesses, gastroenteritis), and soft tissues (ab- lacerations, and wounds) caused by S. scesses, lacerations, wounds), caused aureus, Streptococcus spp., E. coli, and P. by susceptible strains of Staphylococcus mirabilis. aureus, Streptococcus spp., Escherichia (C) Limitations. Federal law restricts coli, Proteus mirabilis, and bacterial der- this drug to use by or on the order of a matitis caused by S. aureus, Strepto- licensed veterinarian. coccus spp., and P. mirabilis. (iii) Limitations. Federal law restricts (ii) Cats—(A) Amount. Administer this drug to use by or on the order of a orally 5 to 10 mg/lb of body weight, licensed veterinarian. once daily for 5 to 7 days. (2) Cats—(i) Amount. Administer oral- (B) Indications for use. Treatment of ly 5 to 10 mg/lb of body weight, once infections caused by susceptible strains daily for 5 to 7 days. of organisms as follows: upper res- (ii) Indications for use. Treatment of piratory tract due to Staphylococcus infections caused by susceptible orga- spp., Streptococcus spp., Haemophilus nisms as follows: upper respiratory spp., E. coli, Pasteurella spp., and P. tract due to S. aureus, Streptococcus mirabilis; genitourinary tract (cystitis) spp., and E. coli; genitourinary tract due to S. aureus, Streptococcus spp., E. (cystitis) due to S. aureus, Streptococcus coli, P. mirabilis, and Corynebacterium spp., E. coli, and P. mirabilis; gastro- spp.; gastrointestinal tract due to E. intestinal tract due to E. coli; and skin coli, Proteus spp., Staphylococcus spp., and soft tissue (abscesses, lacerations, and Streptococcus spp.; skin and soft tis- and wounds) due to S. aureus, Strepto- sue (abscesses, lacerations, and coccus spp., E. coli, and Pasteurella wounds) due to Staphylococcus spp., multocida. Streptococcus spp., E. coli, and (iii) Limitations. Federal law restricts Pasteurella multocida. this drug to use by or on the order of a licensed veterinarian. (C) Limitations. Federal law restricts this drug to use by or on the order of a [57 FR 37319, Aug. 18, 1992, as amended at 60 licensed veterinarian. FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, (2) [Reserved] 2014] (c) Sponsors. See Nos. 000856 and § 520.88b Amoxicillin trihydrate for 051311 in § 510.600(c) of this chapter. oral suspension. (1) Conditions of use. Dogs—(i) Amount. (a) Specifications. When reconstituted, Administer orally 5 mg/lb of body each milliliter contains amoxicillin weight, twice a day for 5 to 7 days. trihydrate equivalent to 50 milligrams (ii) Indications for use. Treatment of (mg) amoxicillin. bacterial dermatitis due to S. aureus, (b) Sponsor. See No. 054771 in Streptococcus spp., Staphylococcus spp., § 510.600(c) of this chapter. and E. coli, and soft tissue infections (1) Conditions of use—(i) Dogs—(A) (abscesses, wounds, lacerations) due to Amount. Administer orally 5 mg per S. aureus, Streptococcus spp., E. coli, P. pound (/lb) of body weight, twice a day mirabilis and Staphylococcus spp. for 5 to 7 days. (iii) Limitations. Federal law restricts (B) Indications for use. Treatment of this drug to use by or on the order of a infections caused by susceptible strains licensed veterinarian. of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) (2) [Reserved] caused by Staphylococcus aureus, Strep- [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. tococcus spp., Escherichia coli, and Pro- 15, 1992, as amended at 60 FR 55658, Nov. 2, teus mirabilis; genitourinary tract (cys- 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, titis) caused by S. aureus, Streptococcus Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR spp., E. coli, and P. mirabilis; gastro- 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; intestinal tract (bacterial 81 FR 17607, Mar. 30, 2016]

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§ 520.88c Amoxicillin trihydrate oral § 520.88e Amoxicillin trihydrate suspension. boluses. (a) Specifications. Each 0.8-milliliter (a) Specifications. Each bolus contains dose contains amoxicillin trihydrate amoxicillin trihydrate equivalent to equivalent to 40 milligrams (mg) 400 milligrams (mg) amoxicillin. amoxicillin. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of (c) Related tolerances. See § 556.510 of this chapter. this chapter. (d) Conditions of use in cattle—(1) (d) Conditions of use in swine—(1) Amount. Administer 400 mg per 100 Amount. Administer 40 mg orally twice a day using a dosing pump. Treat ani- pounds of body weight twice daily. mals for 48 hours after all symptoms Treatment should be continued for 48 have subsided but not beyond 5 days. hours after all symptoms have subsided (2) Indications for use. Treatment of but not to exceed 5 days. baby pigs under 10 pounds for porcine (2) Indications for use. Treatment of colibacillosis caused by Escherichia coli bacterial enteritis when due to suscep- susceptible to amoxicillin. tible Escherichia coli in preruminating (3) Limitations. Do not slaughter dur- calves including veal calves. ing treatment or for 15 days after lat- (3) Limitations. Do not slaughter ani- est treatment. Federal law restricts mals during treatment or for 20 days this drug to use by or on the order of a after the latest treatment. Federal law licensed veterinarian. restricts this drug to use by or on the [57 FR 37319, Aug. 18, 1992, as amended at 60 order of a licensed veterinarian. FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, [57 FR 37320, Aug. 18, 1992, as amended at 60 2014] FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; 79 FR 28817, May 20, 2014] § 520.88d Amoxicillin trihydrate solu- ble powder. § 520.88f Amoxicillin trihydrate tab- (a) Specifications. Each gram of pow- lets. der contains amoxicillin trihydrate (a) Specifications. Each tablet con- equivalent to 115.4 milligrams (mg) tains amoxicillin trihydrate equivalent amoxicillin. to 50, 100, 200, or 400 milligrams (mg) (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. amoxicillin. (c) Related tolerances. See § 556.38 of (b) Sponsors. See Nos. 051311 and this chapter. 054771 in § 510.600(c) of this chapter. (d) Conditions of use in preruminating (c) Conditions of use in dogs—(1) calves including veal calves—(1) Amount. Amount. Administer 5 mg per pound of Administer 400 mg per 100 pounds of body weight twice daily for 5 to 7 days body weight twice daily by drench or in or 48 hours after all symptoms have milk. Treatment should be continued subsided. for 48 hours after all symptoms have (2) Indications for use. For treatment subsided but not to exceed 5 days. of bacterial dermatitis due to Staphy- (2) Indications for use. Treatment of lococcus aureus, Streptococcus spp., bacterial enteritis when due to suscep- Staphylococcus spp., and Escherichia tible Escherichia coli in preruminating coli; and soft tissue infections (ab- calves including veal calves. scesses, wounds, lacerations) due to S. (3) Limitations. Do not slaughter ani- aureus, Streptococcus spp., E. coli, Pro- mals during treatment or for 20 days teus mirabilis, and Staphylococcus spp. after the latest treatment. Federal law (3) Limitations. Federal law restricts restricts this drug to use by or on the this drug to use by or on the order of a order of a licensed veterinarian licensed veterinarian. [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended [79 FR 28817, May 20, 2014] at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 6, 1997; 79 FR 28817, May 20, 2014]

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§ 520.88g Amoxicillin trihydrate and tions (cystitis) due to susceptible clavulanate potassium film-coated strains of E. coli. tablets. (iii) Limitations. Federal law restricts (a) Specifications. Each tablet con- this drug to use by or on the order of a tains amoxicillin trihydrate and licensed veterinarian. clavulanate potassium, equivalent to [57 FR 37320, Aug. 18, 1992, as amended at 60 either 50 milligrams of amoxicillin and FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 12.5 milligrams clavulanic acid, or 100 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, milligrams of amoxicillin and 25 milli- June 16, 2015; 82 FR 11508, Feb. 24, 2017] grams clavulanic acid, or 200 milli- § 520.88h Amoxicillin trihydrate and grams amoxicillin and 50 milligrams clavulanate potassium for oral sus- clavulanic acid or 300 milligrams pension. amoxicillin and 75 milligrams (a) When reconstituted, clavulanic acid. Specifications. each milliliter contains amoxicillin (b) Sponsor. See Nos. 026637 and 054771 trihydrate equivalent to 50 milligrams in § 510.600(c) of this chapter. of amoxicillin with clavulanate potas- (c) Conditions of use—(1) Dogs—(i) sium equivalent to 12.5 milligrams of Amount. 6.25 milligrams (equivalent to clavulanic acid. 5 milligrams amoxicillin and 1.25 milli- (b) Sponsor. See No. 054771 in grams clavulanic acid) per pound of § 510.600(c) of this chapter. body weight twice daily for 5 to 7 days (c) Conditions of use—(1) Dogs—(i) or for 48 hours after all signs have sub- Amount. 6.25 milligrams (equivalent to sided. Deep pyoderma may require 5 milligrams amoxicillin and 1.25 milli- treatment for 21 days; do not treat for grams clavulanic acid) per pound of more than 30 days. body weight twice daily for 5 to 7 days (ii) Indications for use. Treatment of or for 48 hours after all signs have sub- skin and soft tissue infections such as sided. Deep pyoderma may require wounds, abscesses, cellulitis, super- treatment for 21 days; do not treat for ficial/juvenile and deep pyoderma due more than 30 days. to susceptible strains of beta- (ii) Indications for use. Treatment of lactamase (penicillinase) Staphy- skin and soft tissue infections such as lococcus aureus, nonbeta-lactamase S. wounds, abscesses, cellulitis, super- aureus, Staphylococcus spp., Strepto- ficial/juvenile and deep pyoderma due coccus spp., and Escherichia coli. Treat- to susceptible strains of beta- ment of periodontal infections due to lactamase (penicillinase) producing susceptible strains of aerobic and an- Staphylococcus aureus, nonbeta- aerobic bacteria. lactamase Staphylococcus aureus, Staph- (iii) Limitations. Federal law restricts ylococcus spp., Streptococcus spp., and this drug to use by or on the order of a Escherichia coli. Treatment of peri- licensed veterinarian. odontal infections due to susceptible (2) Cats—(i) Amount. 62.5 milligrams strains of aerobic and anaerobic bac- (50 milligrams amoxicillin and 12.5 mil- teria. ligrams clavulanic acid) twice daily for (iii) Limitations. Federal law restricts 5 to 7 days or for 48 hours after all this drug to use by or on the order of a signs have subsided. Urinary tract in- licensed veterinarian. fections may require treatment for 10 (2) Cats—(i) Amount. 62.5 milligrams to 14 days or longer. The maximum du- (1 milliliter) (50 milligrams amoxicillin ration of treatment should not exceed and 12.5 milligrams clavulanic acid) 30 days. twice daily. Administer 48 hours after (ii) Indications for use. Treatment of all signs have subsided. Maximum du- skin and soft tissue infections, such as ration of treatment should not exceed wounds, abscesses and cellulitis/derma- 30 days. titis due to susceptible strains of beta- (ii) Indications for use. Treatment of lactamase (penicillinase) producing S. feline skin and soft tissue infections, aureus, nonbeta-lactamase producing S. such as wounds, abscesses and aureus, Staphylococcus spp., Strepto- cellulitis/dermatitis due to susceptible coccus spp., E. coli, and Pasteurella spp. strains of beta-lactamase (penicil- Also, treatment of urinary tract infec- linase) producing S. aureus, nonbeta-

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lactamase S. aureus, Staphylococcus (c) Conditions of use—(1) Dogs—(i) spp., Streptococcus spp., E. coli, Amount. 5 to 10 milligrams per pound of Pasteurella multocida, and Pasteurella body weight two or three times daily. spp. In severe or acute conditions, 10 milli- (iii) Limitations. Federal law restricts grams per pound of body weight, three this drug to use by or on the order of a times daily. Administer 1 to 2 hours licensed veterinarian. prior to feeding. [57 FR 37320, Aug. 18, 1992, as amended at 60 (ii) Indications for use. Treatment FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, against strains of gram-negative and 1998; 79 FR 28817, May 20, 2014] gram-positive organisms sensitive to ampicillin and associated with res- § 520.90 Ampicillin oral dosage forms. piratory tract infections § 520.90a [Reserved] (tracheobronchitis and tonsillitis); uri- nary tract infections (cystitis); bac- § 520.90b Ampicillin tablets. terial gastroenteritis; generalized in- (a) Specifications. Each tablet con- fections (septicemia) associated with tains ampicillin trihydrate equivalent abscesses, lacerations, and wounds; and to 50 or 100 milligrams of ampicillin. bacterial dermatitis. (b) Sponsor. See No. 054771 in (iii) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. 5 milligrams per pound of body (2) Cats—(i) Amount. 10 to 30 milli- weight, at 8-hour intervals, 1 to 2 hours grams per pound of body weight or prior to feeding, to be continued 36 to three times daily. Administer 1 to 2 48 hours after all symptoms have sub- hours prior to feeding. sided. If no improvement is seen within (ii) Indications for use. Treatment 5 days, stop treatment, reevaluate di- against strains of gram-negative and agnosis, and change therapy. gram-positive organisms sensitive to (2) Indications for use. Oral treatment ampicillin and associated with res- of infections caused by susceptible or- piratory tract infections (bacterial ganisms as follows: Upper respiratory pneumonia); urinary tract infections infections, tonsillitis, and bronchitis (cystitis); and generalized infections due to Streptococcus spp., Staphylococcus (septicemia) associated with abscesses, spp., Escherichia coli, Proteus mirabilis, lacerations, and wounds. and Pasteurella spp., urinary tract in- (iii) Limitations. Federal law restricts fections (cystitis) due to Streptococcus this drug to use by or on the order of a spp., Staphylococcus spp., E., coli, P. licensed veterinarian. mirabilis, and Enterococcus spp.; gastro- intestinal infections due to Staphy- [57 FR 37321, Aug. 18, 1992, as amended at 58 lococcus spp., Streptococcus spp., FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, Enterococcus spp., and E. coli. ; infec- 2014] tions associated with abscesses, lacera- tions, and wounds caused by Staphy- § 520.90d Ampicillin for oral suspen- lococcus spp., and Streptococcus spp. sion. (3) Limitations. Federal law restricts (a) Specifications. When reconstituted this drug to use by or on the order of a as directed, each milliliter contains licensed veterinarian. ampicillin trihydrate equivalent to 25 milligrams of ampicillin. [57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, (b) Sponsor. See No. 055529 in 2014] § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) § 520.90c Ampicillin capsules. Amount. Administer to 10 milligrams (a) Specifications. Each capsule con- per pound of body weight orally, 2 or 3 tains ampicillin trihydrate equivalent times daily, 1 to 2 hours prior to feed- to 125, 250, or 500 milligrams of ampi- ing. In severe or acute conditions, 10 cillin. milligrams per pound of body weight 3 (b) Sponsor. See No. 054771 in times daily. Duration of treatment is § 510.600(c) of this chapter. usually 3 to 5 days. Continue treatment

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48 hours after the animal’s tempera- (d) Conditions of use. Swine—(1) ture has returned to normal and all Amount. 5 milligrams of ampicillin per other signs of infection have subsided. pound of body weight twice daily, oral- (ii) Indications for use. Treatment of ly by gavage or in drinking water for respiratory tract infections up to 5 days. (tracheobronchitis and tonsillitis) due (2) Indications for use. Oral treatment to Escherichia coli, Pseudomonas spp., of porcine colibacillosis (Escherichia Proteus spp., Staphylococcus spp., and coli) and salmonellosis (Salmonella spp.) Streptococcus spp., urinary tract infec- infections in swine up to 75 pounds of tions (cystitis) due to E. coli, Staphy- body weight, and bacterial pneumonia lococcus spp., Streptococcus spp., and caused by Pasteurella multocida, Staphy- Proteus spp.; bacterial gastroenteritis lococcus spp., Streptococcus spp., and due to E. coli; generalized infections Salmonella spp. (septicemia) associated with abscesses, (3) Limitations. Treated swine must lacerations, and wounds, due to Staphy- not be slaughtered for food during lococcus spp. and Streptococcus spp.; bac- treatment and for 24 hours following terial dermatitis due to Staphylococcus the last treatment. Federal law re- spp., Streptococcus spp., Proteus spp., stricts this drug to use by or on the and Pseudomonas spp. order of a licensed veterinarian. (iii) Limitations. Federal law restricts [57 FR 37322, Aug. 18, 1992, as amended at 58 this drug to use by or on the order of a FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, licensed veterinarian. 2014] (2) Cats—(i) Amount. Administer 10 to 30 milligrams per pound of body weight § 520.90f Ampicillin boluses. orally, 2 or 3 times daily, 1 to 2 hours (a) Specifications. Each bolus contains prior to feeding. Duration of treatment ampicillin trihydrate equivalent to 400 is usually 3 to 5 days. Continue treat- milligrams of ampicillin. ment 48 hours after the animal’s tem- (b) Sponsors. See sponsor numbers in perature has returned to normal and § 510.600(c) of this chapter as follows: all other signs of infection have sub- (1) No. 055529 for use as in paragraph sided. (d)(1) of this section; (ii) Indications for use. Treatment of (2) No. 054771 for use as in paragraph respiratory tract infections (bacterial (d)(2) of this section. pneumonia) due to Staphylococcus spp., (c) Related tolerances. See § 556.40 of Streptococcus spp., E. coli, and Proteus this chapter. spp.; urinary tract infections (cystitis) (d) Conditions of use. Nonruminating due to E. coli, Staphylococcus spp., calves—(1) Amount. 5 milligrams per Streptococcus spp., Proteus spp., and pound of body weight twice daily for up Corynebacterium spp.; generalized infec- to 5 days. tions (septicemia) associated with ab- (i) Indications for use. Oral treatment scesses, lacerations, and wounds, due of colibacillosis caused by Escherichia to Staphylococcus spp., Streptococcus coli, bacterial enteritis caused by Sal- spp., Bacillus spp., and Pasteurella spp. monella spp., and bacterial pneumonia (iii) Limitations. Federal law restricts caused by Pasteurella spp. this drug to use by or on the order of a (ii) Limitations. Treated calves must licensed veterinarian. not be slaughtered for food during [57 FR 37321, Aug. 18, 1992, as amended at 58 treatment and for 15 days after the last FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, treatment. Federal law restricts this 2014] drug to use by or on the order of a li- censed veterinarian. § 520.90e Ampicillin for soluble pow- (2) Amount. 5 milligrams per pound of der. body weight twice daily not to exceed 4 (a) Specifications. Each gram contains days. ampicillin trihydrate equivalent to 88.2 (i) Indications for use. Oral treatment milligrams of ampicillin. of bacterial enteritis (colibacillosis) (b) Sponsor. See No. 055529 in caused by E. coli. § 510.600(c) of this chapter. (ii) Limitations. Treated calves must (c) Related tolerances. See § 556.40 of not be slaughtered for food during this chapter. treatment and for 7 days after the last

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treatment. Federal law restricts this (ii) Limitations. Withdraw 24 hours be- drug to use by or on the order of a li- fore slaughter. A withdrawal period has censed veterinarian. not been established for this product in preruminating calves. Do not use in [57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, calves to be processed for veal. Use as 1995; 79 FR 28818, May 20, 2014] the sole source of amprolium. [71 FR 56346, Sept. 27, 2006, as amended at 72 § 520.100 Amprolium. FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, (a) Specifications. (1) Each milliliter 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, of solution contains 96 milligrams (mg) Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR amprolium (9.6 percent solution). 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, (2) Each gram of powder contains 200 2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133, mg amprolium (20 percent). Aug. 29, 2016] (3) Each ounce (28.4 grams) of crum- bles contains 355 mg amprolium (1.25 § 520.110 Apramycin sulfate soluble percent). powder. (b) Sponsors. See sponsors in 510.600(c) (a) Specifications. A water soluble of this chapter. powder used to make a medicated (1) No. 016592 for use of products de- drinking water containing apramycin scribed in paragraph (a) of this section sulfate equivalent to 0.375 gram of as in paragraph (d) of this section. apramycin activity per gallon of drink- (2) No. 066104 for use of product de- ing water. scribed in paragraph (a)(1) of this sec- (b) Sponsor. See No. 058198 in tion as in paragraph (d) of this section. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.50 of (c) Related tolerances. See § 556.52 of this chapter. this chapter. (d) Conditions of use—(1) Growing (d) Conditions of use in swine—(1) chickens, turkeys, and laying hens. It is Amount. Administer in drinking water used in drinking water as follows: at the rate of 12.5 milligrams of (i) Amount. Administer at the 0.012 apramycin per kilogram (5.7 milli- percent level in drinking water as soon grams per pound) of body weight per as coccidiosis is diagnosed and con- day for 7 days. tinue for 3 to 5 days (in severe out- (2) Indications for use. For the control breaks, give amprolium at the 0.024 of porcine colibacillosis (weanling pig percent level); continue with 0.006 per- scours) caused by strains of Escherichia cent amprolium-medicated water for coli sensitive to apramycin. an additional 1 to 2 weeks. (3) Limitations. Do not slaughter (ii)Indications for use. For the treat- treated swine for 28 days following ment of coccidiosis. treatment. Federal law restricts this (iii) Limitations. Use as the sole drug to use by or on the order of a li- source of amprolium. censed veterinarian. (2) Calves. Administer crumbles top- dressed on or thoroughly mixed in the [47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, daily feed ration; administer con- 1988; 79 FR 28818, May 20, 2014; 81 FR 48702, centrate solution or soluble powder as July 26, 2016; 81 FR 94989, Dec. 27, 2016] a drench or in drinking water as fol- lows: § 520.154 Bacitracin oral dosage forms. (i) Indications for use and amounts— (A) As an aid in the prevention of coc- § 520.154a Bacitracin cidiosis caused by Eimeria bovis and E. methylenedisalicylate. zurnii, administer 5 mg per kilogram (a) Specifications. Each pound of solu- (mg/kg) body weight for 21 days during ble powder contains the equivalent of periods of exposure or when experience 50 grams of bacitracin activity for use indicates that coccidiosis is likely to as in paragraph (d)(1) or (d)(2) of this be a hazard. section, or the equivalent of 200 grams (B) As an aid in the treatment of coc- of bacitracin activity for use as in cidiosis caused by E. bovis and E. zurnii, paragraph (d) of this section. administer 10 mg/kg body weight for 5 (b) Sponsor. See No. 054771 in days. § 510.600(c) of this chapter.

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(c) Related tolerances. See § 556.70 of § 520.154b Bacitracin this chapter. methylenedisalicylate and strepto- (d) Conditions of use—(1) Growing tur- mycin sulfate powder. keys—(i) Amount. 400 milligrams (mg) (a) Specifications. Each gram of pow- per gallon (gal) in drinking water. der contains 200 units bacitracin (ii) Indications for use. Aid in the con- methylenedisalicylate and strepto- trol of transmissible enteritis com- mycin sulfate equivalent to 20 milli- plicated by organisms susceptible to grams of streptomycin. bacitracin methylenedisalicylate. (b) Sponsor. See No. 054771 in (iii) Limitations. Prepare a fresh solu- § 510.600(c) of this chapter. tion daily. (c) Conditions of use in dogs—(1) (2) Broiler and replacement chickens— Amount. Administer 1 level teaspoonful (i) Amount. 100 mg per gal in drinking per 10 pounds of body weight three water. times daily, mixed in a small quantity (A) Indications for use. Aid in the pre- of liquid or feed. vention of necrotic enteritis caused by (2) Indications for use. For the treat- Clostridium perfringens susceptible to ment of bacterial enteritis caused by bacitracin methylenedisalicylate. pathogens susceptible to bacitracin and (B) Limitations. Prepare a fresh solu- streptomycin such as Escherichia coli, tion daily. Proteus spp., Staphylococcus spp., and (ii) Amount. 200 to 400 mg per gal in Streptococcus spp., and for the sympto- drinking water. Administer continu- matic treatment of associated diar- ously 5 to 7 days or as long as clinical rhea. signs persist, then reduce to prevention (3) Limitations. Federal law restricts levels (100 mg/gal). this drug to use by or on the order of a licensed veterinarian. (A) Indications for use. Treatment of necrotic enteritis caused by C. [71 FR 17702, Apr. 7, 2006, as amended at 79 perfringens susceptible to bacitracin FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, methylenedisalicylate. 2016] (B) Limitations. Prepare a fresh solu- § 520.154c Bacitracin zinc soluble pow- tion daily. der. (3) Swine—(i) Amount. 1 gram per gal- (a) Specifications. Each pound con- lon in drinking water. tains the equivalent of not less than 5 (ii) Indications for use. Treatment of grams of bacitracin. swine dysentery associated with (b) Sponsor. See No. 054771 in Brachyspira hyodysenteriae. Administer § 510.600(c) of this chapter. continuously for 7 days or until signs (c) Related tolerances. See § 556.70 of of dysentery disappear. this chapter. (iii) Limitations. Prepare a fresh solu- (d) Conditions of use—(1) Broiler chick- tion daily. Treatment not to exceed 14 ens—(i) Amount. 100 milligrams per gal- days. If symptoms persist after 4 to 5 lon in drinking water. days consult a veterinarian. Not to be (A) Indications for use. Prevention of given to swine that weigh more than necrotic enteritis caused by Clostridium 250 pounds. perfringens susceptible to bacitracin (4) Growing quail—(i) Amount. 400 mg zinc. per gal in drinking water. (B) Limitations. Prepare a fresh solu- (ii) Indications for use. For prevention tion daily. of ulcerative enteritis due to Clos- (ii) Amount. 200 to 400 milligrams per tridium colinum susceptible to baci- gallon in drinking water. tracin methylenedisalicylate. (A) Indications for use. Control of ne- (iii) Limitations. Prepare fresh solu- crotic enteritis caused by Clostridium tion daily. Use as sole source of drink- perfringens susceptible to bacitracin ing water. zinc. (B) Limitations. Prepare a fresh solu- [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 63 FR 38474, July 17, tion daily. 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, (2) Growing quail—(i) Amount. 500 mil- Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR ligrams per gallon in drinking water 34278, June 16, 2015] for 5 days followed by 165 milligrams

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per gallon in drinking water for 10 weight. Repeat at intervals of 6 to 12 days. hours as required. Treatment should (ii) Indications for use. Control of ul- not normally be required for longer cerative enteritis caused by Clostridium than 7 days. spp. susceptible to bacitracin zinc. (2) Indications for use. For the relief of (iii) Limitations. Prepare a fresh solu- chronic nonproductive cough associ- tion daily. ated with tracheobronchitis, tracheitis, [57 FR 37322, Aug. 18, 1992, as amended at 67 tonsillitis, laryngitis, and pharyngitis FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, associated with inflammatory condi- 2014] tions of the upper respiratory tract. (3) Limitations. Federal law restricts § 520.222 Bunamidine hydrochloride. this drug to use by or on the order of a (a) Chemical name. N,N-Dibutyl-4- licensed veterinarian. (hexyloxy)-1-naphthamidine hydro- [79 FR 28818, May 20, 2014] chloride. (b) Specifications. The drug is an oral § 520.260 n-Butyl chloride. tablet containing 100, 200, or 400 milli- grams of bunamidine hydrochloride. (a)(1) Specifications. n-Butyl chloride (c) Sponsor. See No. 000061 in capsules, veterinary contain 272 milli- § 510.600(c) of this chapter. grams or 816 milligrams of n-butyl (d) Conditions of use. (1) The drug is chloride in each capsule. intended for oral administration to (2) Sponsor. See No. 021091 in dogs for the treatment of the tape- § 510.600(c) of this chapter. worms Dipylidium caninum, Taenia (3) Conditions of use. (i) It is used for pisiformis, and Echinococcus granulosus, the removal of ascarids (Toxocara canis and to cats for the treatment of the and Toxascaris leonina) and hookworms tapeworms Dipylidium caninum and (Ancylostoma caninum, Ancylostoma Taenia taeniaeformis. braziliense, and Uncinaria stenocephala) (2) It is administered to cats and dogs from dogs and of the ascarid (Toxocara at the rate of 25 to 50 milligrams per cati) and hookworm (Ancylostoma kilogram of body weight. The drug tubaeforme) from cats. should be given on an empty stomach (ii)(a) Animals should not be fed for and food should not be given for 3 18 to 24 hours before being given the hours following treatment. drug. Puppies and kittens should be (3) Tablets should not be crushed, wormed at 6 weeks of age. However, if mixed with food, or dissolved in liquid. heavily infested, they may be wormed Repeat treatments should not be given at 4 or 5 weeks of age. Administration within 14 days. The drug should not be of the drug should be followed in 1⁄2 to given to male dogs within 28 days prior 1 hour with a teaspoonful to a table- to their use for breeding. Do not ad- spoonful of milk of magnesia or 1 or 2 minister to dogs or cats having known milk of magnesia tablets. Normal ra- heart conditions. tions may be resumed 4 to 8 hours after (4) For use only by or on the order of treatment. Puppies and kittens should a licensed veterinarian. be given a repeat treatment in a week [40 FR 13838, Mar. 27, 1975, as amended at 42 or 10 days. After that they should be FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, treated every 2 months (or as symp- 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, toms reappear) until a year old. When Nov. 19, 1997] the puppy or kitten is a year old, one treatment every 3 to 6 months is suffi- § 520.246 Butorphanol tablets. cient. (a) Specifications. Each tablet con- (b) For dogs or cats that have been tains butorphanol tartrate equivalent wormed regularly, treatment every 3 to to 1, 5, or 10 milligrams (mg) 6 months will be sufficient. If a dog or butorphanol base. cat has not been wormed previously (b) Sponsor. See No. 054771 in and has the symptoms of large § 510.600(c) of this chapter. roundworms a dose should be given and (c) Conditions of use in dogs—(1) repeated in 10 days. Removal of Amount. Administer 0.25 mg hookworms may require 3 or 4 doses at butorphanol base per pound of body 10-day intervals.

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(c) Puppies, dogs, cats, or kittens n-butyl chloride are administered to weighing 1 to 3 pounds should be given dogs as follows: Weighing under 5 2 capsules per dose which contain 272 pounds, 1 capsule; weighing 5 to 10 milligrams of n-butyl chloride each. pounds, 2 capsules; weighing 10 to 20 Such animals weighing 4 to 5 pounds pounds, 3 capsules; weighing 20 to 40 should be given 3 such capsules. Ani- pounds, 4 capsules; over 40 pounds, 5 mals weighing 6 to 7 pounds should be capsules. Capsules containing 1,768 mil- given 4 such capsules and animals ligrams of n-butyl chloride are admin- weighing 8 to 9 pounds should be given istered at a dosage level of 1 capsule 5 such capsules. Animals weighing 10 to per dog weighing 5 to 10 pounds. Cap- 20 pounds should be given 3 capsules sules containing 4.42 grams of n-butyl which contain 816 milligrams of n- chloride are administered at a dosage butyl chloride each, animals weighing level of 1 capsule per dog weighing 40 20 to 40 pounds should be given 4 such pounds or over. capsules and animals weighing over 40 (iii) A veterinarian should be con- pounds should be given 5 such capsules sulted before using in severely debili- with the maximum dosage being 5 cap- tated dogs. sules, each of which contains 816 milli- grams of n-butyl chloride. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 44 FR 10059, Feb. 16, (iii) A veterinarian should be con- 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, sulted before using in severely debili- June 18, 1990; 64 FR 15684, Apr. 1, 1999; 70 FR tated dogs or cats and also prior to re- 50182, Aug. 26, 2005; 78 FR 14669, Mar. 7, 2013; peated use in cases which present signs 79 FR 28818, May 20, 2014] of persistent parasitism. EDITORIAL NOTE: At 78 FR 14669, Mar. 7, (b)(1) Specifications. n-Butyl chloride 2013, § 520.260 was amended by adding para- capsules contain 221, 442, 884, or 1,768 graphs (b)(1) through (3); however, the milligrams or 4.42 grams of n-butyl amendment could not be incorporated be- chloride in each capsule. cause (b)(1) through (3) already existed. (2) Sponsors. See No. 023851 in § 510.600(c) of this chapter for 221, 442, § 520.284 Cambendazole oral dosage 884, or 1,768 milligram or 4.42 gram cap- forms. sules; No. 038782 for 884 or 1,768 milli- § 520.284a Cambendazole suspension. gram or 4.42 gram capsules; and No. 054771 for 221 milligram capsules. (a) Specifications. Each fluid ounce (3) Conditions of use. (i) It is used for contains 0.9 gram of cambendazole. the removal of ascarids (Toxocara canis (b) Sponsor. No. 050604 in § 510.600(c) of and Toxascaris leonina) and hookworms this chapter. (Ancylostoma caninum, Ancylostoma (c) Conditions of use in horses—(1) braziliense, and Uncinaria stenocephala) Amount. Administer by stomach tube from dogs. or as a drench at a dose of 0.9 gram of (ii)(a) Dogs should not be fed for 18 to cambendazole per 100 pounds of body 24 hours before being given the drug. weight (20 milligrams per kilogram). Administration of the drug should be (2) Indications for use. For the control followed in 1⁄2 to 1 hour with a mild ca- of large strongyles (Strongylus vulgaris, thartic. Normal feeding may be re- S. edentatus, S. equinus); small sumed 4 to 8 hours after treatment. strongyles (Trichonema, Poteriostomum, Animals subject to reinfection may be Cylicobrachytus, Craterostomum, retreated in 2 weeks. Oesophagodontus); roundworms (b) The drug is administered orally to (Parascaris); pinworms (Oxyuris); and dogs. Capsules containing 221 milli- threadworms (Strongyloides). grams of n-butyl chloride are adminis- (3) Limitations. Do not use in horses tered to dogs weighing under 5 pounds intended for human consumption. Fed- at a dosage level of 1 capsule per 11⁄4 eral law restricts this drug to use by or pound of body weight. Capsules con- on the order of a licensed veterinarian. taining 442 milligrams of n-butyl chlo- [40 FR 13838, Mar. 27, 1975. Redesignated at 41 ride are administered to dogs weighing FR 1276, Jan. 7, 1976, and amended at 42 FR under 5 pounds at a dosage level of 1 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; capsule per 21⁄2 pounds body weight. 79 FR 28818, May 20, 2014. Redesignated at 81 Capsules containing 884 milligrams of FR 59133, Aug. 29, 2016]

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§ 520.284b Cambendazole pellets. Cylicobrachytus, Craterostomum, (a) Specifications. The drug is in feed Oesophagodontus); roundworms pellets containing 5.3 percent (Parascaris); pinworms (Oxyuris); and cambendazole. threadworms (Strongyloides). (b) Sponsor. No. 050604 in § 510.600(c) of (3) Limitations. Do not administer to this chapter. pregnant mares during first 3 months (c) Conditions of use in horses—(1) of pregnancy. Do not use in horses in- Amount. Administer 20 milligrams tended for human consumption. Con- cambendazole per kilogram body sult your veterinarian for assistance in weight (6 ounces per 1,000 pounds) by the diagnosis, treatment, and control mixing with normal grain ration given of parasitism. at one feeding. Doses for individual [41 FR 1276, Jan. 7, 1976, as amended at 42 FR horses should be mixed and fed sepa- 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; rately to assure that each horse will 79 FR 28819, May 20, 2014. Redesignated at 81 consume the correct amount. For ani- FR 59133, Aug. 29, 2016] mals maintained on premises where re- infection is likely to occur, re-treat- § 520.292 Capromorelin. ments may be necessary. For most ef- (a) Specifications. Each milliliter of fective results, re-treat in 6 to 8 weeks. solution contains 30 milligrams (mg) (2) Indications for use. For the control capromorelin. of large strongyles (Strongylus vulgaris, (b) Sponsor. See No. 086026 in S. edentatus, S. equinus); small § 510.600(c) of this chapter. strongyles (Trichonema, Poteriostomum, (c) Conditions of use in dogs—(1) Cylicobrachytus, Craterostomum, Amount. Administer 3 mg/kg once daily Oesophagodontus); roundworms by mouth. (Parascaris); pinworms (Oxyuris); and (2) For appetite threadworms (Strongyloides). Indications for use. (3) Limitations. Do not administer to stimulation in dogs. pregnant mares during first 3 months (3) Limitations. Federal law restricts of pregnancy. Do not use in horses in- this drug to use by or on the order of a tended for human consumption. Con- licensed veterinarian. sult your veterinarian for assistance in [81 FR 59133, Aug. 29, 2016] the diagnosis, treatment, and control of parasitism. § 520.301 Caramiphen ethanedisulfonate and ammonium [41 FR 1276, Jan. 7, 1976, as amended at 42 FR chloride tablets. 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 FR 28818, May 20, 2014. Redesignated at 81 (a) Specifications. Each tablet con- FR 59133, Aug. 29, 2016] tains 10 milligrams of 5st caramiphen ethanedisulfonate and 80 milligrams of § 520.284c Cambendazole paste. ammonium chloride. (a) Specifications. The drug is a paste (b) Sponsor. See No. 054771 in containing 45 percent cambendazole. § 510.600(c) of this chapter. (b) Sponsor. No. 050604 in § 510.600(c) of (c) Conditions of use in dogs—(1) this chapter. Amount. One tablet per 15 to 30 pounds (c) Conditions of use in horses—(1) of body weight every 4 to 6 hours. Amount. Administer 20 milligrams (2) Indications for use. For relief of cambendazole per kilogram body cough. weight (5 grams per 550 pounds (250 kilograms)) by depositing the paste on [43 FR 55385, Nov. 28, 1978, as amended at 79 the back of the tongue using a dosing FR 28819, May 20, 2014. Redesignated at 80 FR gun. For animals maintained on prem- 13229, Mar. 13, 2015] ises where reinfection is likely to § 520.302 Carnidazole tablets. occur, re-treatments may be necessary. For most effective results, re-treat in 6 (a) Specifications. Each tablet con- to 8 weeks. tains 10 milligrams of carnidazole. (2) Indications for use. For the control (b) Sponsor. See 053923 in § 510.600(c) of of large strongyles (Strongylus vulgaris, this chapter. S. edentatus, S. equinus); small (c) Conditions of use—(1) Amount. strongyles (Trichonema, Poteriostomum, Adult pigeons: 1 tablet (10 milligrams);

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newly weaned pigeons: 1⁄2 tablet (5 mil- § 520.314 Cefadroxil. ligrams). (a) Specifications. (1) Each tablet con- (2) Indications for use. For treating tains 50, 100, or 200 milligrams (mg) or trichomoniasis (canker) in ornamental 1 gram of cefadroxil. and homing pigeons. (2) Each milliliter of suspension con- (3) Limitations. Not for use in pigeons stituted from powder contains 50 mg of intended for human food. Consult your cefadroxil. veterinarian for assistance in the diag- nosis, treatment, and control of para- (b) Sponsor. See No. 000010 in sitism or when severely ill birds do not § 510.600(c) of this chapter. respond to treatment. (c) Conditions of use in dogs and cats— (1) Amount—(i) Dogs. Administer 10 mg [54 FR 32336, Aug. 7, 1989. Redesignated at 80 per pound (/lb) body weight twice daily FR 13229, Mar. 13, 2015] orally. (ii) Cats. Administer 10 mg/lb body § 520.304 Carprofen. weight once daily orally. (a) Specifications. (1) Each caplet con- (2) Indications for use—(i) Dogs. For tains 25, 75, or 100 milligrams (mg) the treatment of skin and soft tissue carprofen. infections including cellulitis, (2) Each chewable tablet contains 25, pyoderma, dermatitis, wound infec- 75, or 100 mg carprofen. tions, and abscesses due to susceptible (b) Sponsors. See sponsors in strains of Staphylococcus aureus. For § 510.600(c) of this chapter for uses as in the treatment of genitourinary tract paragraph (d) of this section. infections (cystitis) due to susceptible (1) No. 054771 for use of products de- strains of Escherichia coli, Proteus scribed in paragraph (a) of this section mirabilis, and S. aureus. as in paragraph (d) of this section. (ii) Cats. For the treatment of skin (2) Nos. 000859, 026637, 055529, and and soft tissue infections including ab- 062250 for use of product described in scesses, wound infections, cellulitis, paragraph (a)(1) as in paragraph (d) of and dermatitis caused by susceptible this section. strains of Pasteurella multocida, S. (3) Nos. 026637 and 062250 for use of aureus, Staphylococcus epidermidis, and product described in paragraph (a)(2) of Streptococcus spp. this section as in paragraph (d) of this (3) Limitations. Federal law restricts section. this drug to use by or on the order of a (c) [Reserved] licensed veterinarian. (d) Conditions of use in dogs—(1) Amount. 2 mg per pound (/lb) of body [75 FR 10165, Mar. 5, 2010] weight once daily or 1 mg/lb twice daily. For the control of postoperative § 520.370 Cefpodoxime tablets. pain, administer approximately 2 hours (a) Specifications. (1) Each tablet con- before the procedure. tains cefpodoxime proxetil equivalent (2) Indications for use. For the relief of to 100 or 200 milligrams (mg) pain and inflammation associated with cefpodoxime. osteoarthritis and for the control of (2) Each chewable tablet contains postoperative pain associated with soft cefpodoxime proxetil equivalent to 100 tissue and orthopedic surgeries. or 200 mg cefpodoxime. (3) Limitations. Federal Law restricts (b) Sponsors. See sponsors in this drug to use by or on the order of a § 510.600(c) of this chapter for uses as licensed veterinarian. follows: [61 FR 66581, Dec. 18, 1996, as amended at 64 (1) No. 026637 for use of product in FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, paragraph (a)(1) of this section as in 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, paragraph (c) of this section. Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR (2) No. 054771 for use of products in 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; paragraph (a) of this section as in para- 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, graph (c) of this section. 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redes- (c) Conditions of use in dogs—(1) ignated and amended at 80 FR 13229, Mar. 13, Amount. 5 to 10 mg per kilogram (2.3 to 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, 4.5 mg per pound) body weight daily for Oct. 13, 2015] 5 to 7 days, or for 2 to 3 days beyond

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the cessation of clinical signs, up to a (ii) [Reserved] maximum of 28 days. (c) Conditions of use in dogs—(1) (2) Indications for use. For the treat- Amount. Administer 25 mg per pound of ment of skin infections (wounds and body weight by mouth every 6 hours. abscesses) caused by susceptible strains (2) Indications for use—(i) For the of Staphylococcus pseudintermedius, S. treatment of bacterial pulmonary in- aureus, Streptococcus canis (group G, fections, bacterial infections of the uri- beta-hemolytic), Escherichia coli, nary tract, bacterial enteritis, and bac- Pasteurella multocida, and Proteus terial infections associated with canine mirabilis. distemper caused by susceptible orga- (3) Limitations. Federal law restricts nisms. this drug to use by or on the order of a (ii) For the treatment of bacterial licensed veterinarian. gastroenteritis associated with bac- terial diarrhea, bacterial pulmonary [69 FR 52815, Aug. 30, 2004, as amended at 78 infections, and bacterial infections of FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, the urinary tract caused by susceptible Mar. 1, 2017] organisms. (3) Limitations. Federal law restricts § 520.376 Cephalexin. this drug to use by or on the order of a (a) Specifications. Each chewable tab- licensed veterinarian. Federal law pro- let contains 75, 150, 300, or 600 milli- hibits the extralabel use of this drug in grams (mg) cephalexin. food-producing animals. (b) Sponsor. See No. 051311 in [77 FR 4896, Feb. 1, 2012, as amended at 78 FR § 510.600(c) of this chapter. 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014] (c) Conditions of use—(1) Dogs—(i) Amount. Administer 22 mg per kilo- § 520.390b Chloramphenicol capsules. gram of body weight twice daily for 28 (a) Specifications. Each capsule con- days. tains 50, 100, 250, or 500 milligrams (mg) (ii) Indications for use. For the treat- chloramphenicol. ment of secondary superficial bacterial (b) Sponsors. See Nos. 050057 and pyoderma in dogs caused by susceptible 054771 in § 510.600(c) of this chapter for strains of Staphylococcus use as in paragraph (d) of this section. pseudintermedius. (c) Special considerations. Federal law (iii) Limitations. Federal law restricts prohibits the extralabel use of this this drug to use by or on the order of a product in food-producing animals. licensed veterinarian. (d) Conditions of use in dogs—(1) (2) [Reserved] Amount. 25 mg per pound of body weight every 6 hours. [77 FR 47512, Aug. 9, 2012] (2) Indications for use. For treatment § 520.390 Chloramphenicol oral dosage of bacterial pulmonary infections, bac- forms. terial infections of the urinary tract, bacterial enteritis, and bacterial infec- § 520.390a Chloramphenicol tablets. tions associated with canine distemper (a) Specifications. Each tablet con- caused by susceptible organisms. tains 50, 100, 250, or 500 milligrams (3) Limitations. Federal law restricts (mg); 1 or 2.5 grams (g) of chloramphen- this drug to use by or on the order of a icol. licensed veterinarian. (b) Sponsors. See § 510.600(c) of this [70 FR 75398, Dec. 20, 2005, as amended at 73 chapter: FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, (1) For use as in paragraphs (c)(1), 2010; 79 FR 28819, May 20, 2014] (c)(2)(i), and (c)(3) of this section: (i) No. 054628 for 100-, 250-, and 500-mg; § 520.390c Chloramphenicol palmitate and 1- and 2.5-g tablets; oral suspension. (ii) No. 054771 for 100-, 250-, and 500- (a) Specifications. Each milliliter con- mg tablets; tains chloramphenicol palmitate equiv- (2) For use as in paragraphs (c)(1), alent to 30 milligrams of chloramphen- (c)(2)(ii), and (c)(3) of this section: icol. (i) No. 061623 for 50-, 100-, 250-, and (b) Sponsor. See No. 054771 in 500-mg; and 1-g tablets; § 510.600(c) of this chapter.

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(c) Conditions of use. Dogs—(1) tion to sodium is excessive; the plasma Amount. 25 milligrams per pound of bicarbonate level increases and body weight every 6 hours. If no re- alkalosis results). Federal law restricts sponse is obtained in 3 to 5 days, dis- this drug to use by or on the order of a continue use and reevaluate diagnosis. licensed veterinarian. (2) Indications for use. Treatment of (b)(1) Specifications. Each bolus con- bacterial pulmonary infections, infec- tains 2 grams of chlorothiazide. tions of the urinary tract, enteritis, (2) Sponsor. See No. 000006 in and infections associated with canine § 510.600(c) of this chapter. distemper that are caused by orga- (3) —(i) 2 nisms susceptible to chloramphenicol. Conditions of use Amount. (3) Limitations. Not for use in animals grams once or twice daily for 3 or 4 that are raised for food production. days. Must not be used in meat-, egg-, or (ii) Indications for use. For use in cat- milk-producing animals. The length of tle as an aid in reduction of time that residues persist in milk or postparturient udder edema. tissues has not been determined. Fed- (iii) Limitations. Animals should be eral law restricts this drug to use by or regularly and carefully observed for on the order of a licensed veterinarian. early signs of fluid and electrolyte im- [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. balance. Take appropriate counter- 15, 1992, as amended at 79 FR 28819, May 20, measures if this should occur. Milk 2014] taken from dairy animals during treat- ment and for 72 hours (six milkings) § 520.420 Chlorothiazide tablets and after latest treatment must not be boluses. used for food. Federal law restricts this (a)(1) Specifications. Each tablet con- drug to use by or on the order of a li- tains 0.25 gram of chlorothiazide. censed veterinarian. (2) Sponsor. See No. 050604 in § 510.600(c) of this chapter. [43 FR 39085, Sept. 1, 1978, as amended at 62 (3) Conditions of use—(i) Amount. FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, Usual dosage is 5 to 10 milligrams per 2014] pound of body weight two or three times daily. § 520.434 Chlorphenesin carbamate tablets. (ii) Indications for use. For use in dogs for treatment of congestive heart fail- (a) Specifications. Each tablet con- ure and renal edema. tains 400 milligrams of chlorphenesin (iii) Limitations. (a) Dosage must be carbamate. adjusted to meet the changing needs of (b) Sponsor. See No. 054771 in the individual animal. In mild and re- § 510.600(c) of this chapter. sponsive cases, it is suggested that a (c) Conditions of use in dogs—(1) dose of 5 milligrams per pound of body Amount. 50 milligrams per pound of weight be administered two or three body weight on first day; 25 milligrams times daily. In moderately edematous per pound of body weight each fol- and moderately responsive animals, a lowing day. Divide total daily dose into dose of 7.5 to 10 milligrams per pound 2 or 3 equal doses—administer at 12- or of body weight may be administered 8-hour intervals. three times daily. Severe conditions may require higher doses. Certain ani- (2) Indications for use. For use as an mals may respond adequately to inter- adjunct to therapy of acute inflam- mittent therapy; in these cases, the matory and traumatic conditions of drug may be administered either every skeletal muscles. The drug provides re- other day or for 3 to 5 days each week. lief of the signs of discomfort associ- (b) Animals should be regularly and ated with myositis, muscle sprains, carefully observed for early signs of traumatic injuries, stifle injuries—es- fluid and electrolyte imbalance. Take pecially when administered before or appropriate countermeasures if this after surgery—and invertebral disc should occur. In some dogs, syndrome (can be used concurrently hypochloremic alkalosis may occur with adrenal corticosteroids). (that is, excretion of chloride in rela-

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(3) Limitations. Federal law restricts fever) associated with Pasteurella spp., this drug to use by or on the order of a A. pleuropneumoniae (Haemophilus spp.), licensed veterinarian. and Klebsiella spp. [44 FR 16009, Mar. 16, 1979, as amended at 79 (2) Limitations. Prepare fresh solution FR 28819, May 20, 2014] daily; as sole source of chlortetra- cycline; administer for not more than 5 § 520.441 Chlortetracycline powder. days; do not slaughter animals for food (a) Specifications. Chlortetracycline within 24 hours of treatment; do not powder contains not less than 15 milli- administer this product with milk or grams per gram chlortetracycline hy- milk replacers; administer 1 hour be- drochloride, or chlortetracycline bisul- fore or 2 hours after feeding milk or fate equivalent to 25.6, 64 or 102.4 grams milk replacers; a withdrawal period has per pound (56.4, 141 or 225.6 milligrams not been established in preruminating per gram) chlortetracycline hydro- calves; do not use in calves to be proc- chloride. essed for veal. Federal law restricts (b) Sponsors. See sponsors in this drug to use by or on the order of a § 510.600(c) of this chapter for use as in licensed veterinarian. paragraph (d) of this section. (B) [Reserved] (1) Nos. 000010, 016592, 054771, and (ii) [Reserved] 069254 for use as in paragraph (d) of this (3) [Reserved] section. (4) The following uses of chlortetra- (2) No. 066104 for use as in paragraphs cycline hydrochloride or chlortetra- (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) cycline bisulfate in drinking water or through (d)(4)(iv) of this section. drench were reviewed by the National (3) Nos. 069254 and 076475 for use as in Academy of Sciences/National Re- paragraphs (d)(4)(i)(A), (d)(4)(i)(B), search Council (NAS/NRC) and found (d)(4)(ii), and (d)(4)(iii) of this section. effective: (c) Related tolerances. See § 556.150 of (i) Chickens—(A) Amount. 200 to 400 this chapter. milligrams per gallon. (d) Conditions of use. (1) Use as chlor- (1) Indications for use. Control of in- tetracycline hydrochloride in drinking fectious synovitis caused by Myco- water as follows: plasma synoviae. (i) Swine—(A) Amount. Ten milli- (2) Limitations. Prepare fresh solution grams per pound of body weight daily daily; as sole source of chlortetra- in divided doses. cycline; do not use for more than 14 (1) Indications for use. Control and days; do not slaughter animals for food treatment of bacterial enteritis within 24 hours of treatment; do not (scours) caused by Escherichia coli and use in laying chickens. Federal law re- bacterial pneumonia associated with stricts this drug to use by or on the Pasteurella spp., Actinobacillus order of a licensed veterinarian. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp. (B) Amount. 400 to 800 milligrams per (2) Limitations. Prepare a fresh solu- gallon. tion twice daily; as sole source of (1) Indications for use. Control of chlortetracycline; administer for not chronic respiratory disease and air-sac more than 5 days. Federal law restricts infections caused by M. gallisepticum this drug to use by or on the order of a and E. coli. licensed veterinarian. (2) Limitations. Prepare fresh solution (B) [Reserved] daily; as sole source of chlortetra- (ii) [Reserved] cycline; do not use for more than 14 (2) Use as chlortetracycline hydro- days; do not slaughter animals for food chloride in a drench or drinking water within 24 hours of treatment; do not as follows: use in laying chickens. Federal law re- (i) Calves—(A) Amount. Ten milli- stricts this drug to use by or on the grams per pound of body weight daily order of a licensed veterinarian. in divided doses. (C) Amount. One thousand milligrams (1) Control and treatment of bac- per gallon. terial enteritis (scours) caused by E. (1) Indications for use. Control of mor- coli and bacterial pneumonia (shipping tality due to fowl cholera caused by

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Pasteurella multocida susceptible to pleuropneumoniae (Haemophilus spp.), chlortetracycline. and Klebsiella spp. (2) Limitations. See paragraph (C) Limitations. Prepare fresh solution (d)(4)(i)(A)(2) of this section. daily; use as a drench; as sole source of (ii) Growing turkeys—(A) Amount. 400 chlortetracycline; do not use for more milligrams per gallon. than 5 days; do not slaughter animals (1) Indications for use. Control of in- for food within 24 hours of treatment; fectious synovitis caused by M. do not use in lactating cattle; do not synoviae. administer this product with milk or (2) Limitations. Prepare fresh solution milk replacers; administer 1 hour be- daily; as sole source of chlortetra- fore or 2 hours after feeding milk or cycline; do not use for more than 14 milk replacers; a withdrawal period has days; do not slaughter animals for food not been established in preruminating within 24 hours of treatment. Federal calves; do not use in calves to be proc- law restricts this drug to use by or on essed for veal. Federal law restricts the order of a licensed veterinarian. this drug to use by or on the order of a (B) Amount. 25 milligrams per pound licensed veterinarian. of body weight daily. (5) Use in a drench or drinking water (1) Indications for use. Control of com- as follows: plicating bacterial organisms associ- (i) Chickens—(A) Amount. 200 to 400 ated with bluecomb (transmissible en- mg/gal, for 7 to 14 days. teritis, coronaviral enteritis). (1) Indications for use. Control of in- (2) Limitations. Prepare fresh solution fectious synovitis caused by M. daily; as sole source of chlortetra- synoviae susceptible to chlortetra- cycline; do not use for more than 14 cycline. days; do not slaughter animals for food (2) Limitations. Prepare fresh solution within 24 hours of treatment. Federal daily; use as the sole source of chlor- law restricts this drug to use by or on tetracycline; do not use for more than the order of a licensed veterinarian. 14 consecutive days; do not use in lay- (iii) Swine—(A) Amount. 10 milligrams ing chickens; do not administer to per pound body weight daily in divided chickens within 24 hours of slaughter. doses. Federal law restricts this drug to use (B) Indications for use. Control and by or on the order of a licensed veteri- treatment of bacterial enteritis narian. (scours) caused by E. coli and Sal- (B) Amount. 400 to 800 mg/gal, for 7 to monella spp. and bacterial pneumonia 14 days. associated with Pasteurella spp., (1) Indications for use. Control of Actinobacillus pleuropneumoniae chronic respiratory disease (CRD) and (Haemophilus spp.), and Klebsiella spp. air-sac infections caused by M. (C) Limitations. Prepare fresh solution gallisepticum and E. coli susceptible to daily; as sole source of chlortetra- chlortetracycline. cycline; do not use for more than 5 days. For Nos. 016592 and 021930, do not (2) Limitations. As in paragraph slaughter animals for food within 5 (d)(5)(i)(A)(2) of this section. days of treatment. For No. 016592, do (C) Amount. One thousand mg/gal, for not slaughter animals for food within 7 to 14 days. 24 hours of treatment. Federal law re- (1) Indications for use. Control of mor- stricts this drug to use by or on the tality due to fowl cholera caused by order of a licensed veterinarian. Pasteurella multocida susceptible to (iv) Calves, beef cattle, and nonlac- chlortetracycline. tating dairy cattle—(A) Amount. 10 milli- (2) Limitations. As in paragraph grams per pound daily in divided doses. (d)(5)(i)(A)(2) of this section. (B) Indications for use. Control and (ii) Growing Turkeys—(A) Amount. 400 treatment of bacterial enteritis mg/gal, for 7 to 14 days. (scours) caused by E. coli and Sal- (1) Indications for use. Control of in- monella spp. and bacterial pneumonia fectious synovitis caused by Myco- (shipping fever complex) associated plasma synoviae susceptible to chlor- with Pasteurella spp., A. tetracycline.

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(2) Limitations. Prepare fresh solution this drug to use by or on the order of a daily; use as the sole source of chlor- licensed veterinarian. tetracycline; do not use for more than [57 FR 37324, Aug. 18, 1992] 14 consecutive days; do not administer to growing turkeys within 24 hours of EDITORIAL NOTE: For FEDERAL REGISTER ci- slaughter. Federal law restricts this tations affecting § 520.441, see the List of CFR Sections Affected, which appears in the drug to use by or on the order of a li- Finding Aids section of the printed volume censed veterinarian. and at www.fdsys.gov. (B) Amount. 25 mg/lb body weight daily, for 7 to 14 days. § 520.443 Chlortetracycline tablets and (1) Indications for use. Control of com- boluses. plicating bacterial organisms associ- (a) Specifications. Each tablet/bolus ated with bluecomb (transmissible en- contains 25, 250, or 500 milligrams (mg) teritis, coronaviral enteritis) suscep- chlortetracycline hydrochloride. tible to chlortetracycline. (b) Sponsor. See Nos. 016592 and 054628 (2) Limitations. As in paragraph in § 510.600(c) of this chapter. (d)(5)(ii)(A)(2) of this section. (c) Related tolerances. See § 556.150 of (iii) Swine—(A) Amount. 10 mg/lb body this chapter. weight daily, for 3 to 5 days. (d) Conditions of use in calves—(1) (B) Indications for use. Control and Amount. One 250 milligram bolus per 50 treatment of bacterial enteritis pounds of body weight twice a day for (scours) caused by E. coli and Sal- 3 to 5 days. monella spp., and bacterial pneumonia (i) Indications for use. Treatment of associated with Pasteurella spp., A. bacterial enteritis (scours) caused by pleuropneumoniae, and Klebsiella spp. Escherichia coli and bacterial pneu- susceptible to chlortetracycline. monia associated with Pasteurella spp., (C) Limitations. Prepare fresh solution Klesbsiella spp., and Haemophilus spp. daily; use as the sole source of chlor- (ii) Limitations. Administer bolus di- tetracycline; do not use for more than rectly by mouth or crush and dissolve 5 days; do not administer to swine in milk or water for drenching or buck- within 24 hours of slaughter. Federal et feeding; if no improvement is noted law restricts this drug to use by or on after 3 days of treatment, consult a veterinarian; do not use for more than the order of a licensed veterinarian. 5 days; do not administer within 24 (iv) Calves, beef cattle, and nonlac- hours of slaughter. tating dairy cattle—(A) Amount. 10 mg/lb (2) Amount. One 25 milligram tablet body weight daily in divided doses, for for each 5 pounds of body weight every 3 to 5 days. 12 hours daily for 3 to 5 days. (B) Indications for use. Control and (i) Indications for use. Control and treatment of bacterial enteritis treatment of bacterial enteritis (scours) caused by Escherichia coli and (scours) caused by E. coli and Sal- Salmonella spp., and bacterial pneu- monella spp. and bacterial pneumonia monia associated with Pasteurella spp., associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. sus- Haemophilus spp., and Klebsiella spp., ceptible to chlortetracycline. susceptible to chlortetracycline. (C) Limitations. Prepare fresh solution (ii) Limitations. Administer tablet di- daily; use as a drench; use as the sole rectly by mouth or crush and dissolve source of chlortetracycline; do not use in water for drenching; if no improve- for more than 5 days; do not administer ment is noted after 3 days of treat- to cattle within 24 hours of slaughter; ment, consult a veterinarian; do not do not use in lactating dairy cattle; do use for more than 5 days; when feeding not administer this product with milk milk or milk replacer, administration 1 or milk replacers; administer 1 hour hour before or 2 hours after feeding; do before or 2 hours after feeding milk or not administer within 24 hours of milk replacers; a withdrawal period has slaughter. not been established in preruminating (3) Amount. One 500 milligram bolus calves; do not use in calves to be proc- per 100 pounds of body weight twice a essed for veal. Federal law restricts day for 3 to 5 days.

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(i) Indications for use. Treatment of (2) Each tablet contains the equiva- bacterial enteritis (scours) caused by E. lent of 25, 75, or 150 mg clindamycin as coli and Salmonella spp., and bacterial the hydrochloride salt. pneumonia associated with Pasteurella (3) Each capsule contains the equiva- spp., Haemophilus spp., and Klebsiella lent of 25, 75, or 150 mg clindamycin as spp., susceptible to chlortetracycline. the hydrochloride salt. (ii) Limitations. Administer directly (b) Sponsors. See sponsors in by mouth or crush and dissolve in § 510.600(c) of this chapter as follows: water for drenching; if no improvement (1) Nos. 054771 and 069043 for use of is noted after 3 days of treatment, con- capsules described in paragraph (a)(1) sult a veterinarian; do not use for more of this section. than 5 days; do not administer within (2) No. 051311 for use of tablets de- 24 hours of slaughter. scribed in paragraph (a)(2) of this sec- [57 FR 37325, Aug. 18, 1992, as amended at 67 tion. FR 78355, Dec. 24, 2002. Redesignated and (3) No. 043806 for use of tablets de- amended at 76 FR 49649, Aug. 11, 2011; 78 FR scribed in paragraph (a)(3) of this sec- 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016] tion. (c) Conditions of use in dogs—(1) § 520.445 Chlortetracycline and Amount. Wounds, abscesses, and dental sulfamethazine powder. infections: 2.5 to 15 mg per pound (/lb) (a) Specifications. Each pound of solu- body weight every 12 hours for a max- ble powder contains chlortetracycline imum of 28 days. Osteomyelitis: 5.0 to bisulfate equivalent to 102.4 grams (g) 15 mg/lb body weight every 12 hours for of chlortetracycline hydrochloride and a minimum of 28 days. sulfamethazine bisulfate equivalent to (2) Indications for use. For the treat- 102.4 g of sulfamethazine. ment of skin infections (wounds and (b) Sponsor. See No. 016592 in abscesses) due to susceptible strains of § 510.600(c) of this chapter. coagulase-positive staphylococci (c) Related tolerances. See §§ 556.150 (Staphylococcus aureus or S. and 556.670 of this chapter. intermedius), deep wounds and abscesses (d) Conditions of use in swine. Admin- due to susceptible strains of Bacteroides ister in drinking water as follows: fragilis, Prevotella melaninogenicus, (1) Amount. 250 milligrams (mg) of Fusobacterium necrophorum, and Clos- chlortetracycline and 250 mg of tridium perfringens, dental infections sulfamethazine per gallon. due to susceptible strains of S. aureus, (2) Indications for use. For the preven- B. fragilis, P. melaninogenicus, F. tion and treatment of bacterial enter- necrophorum, and C. perfringens, and os- itis; as an aid in the reduction of the teomyelitis due to susceptible strains incidence of cervical abscesses; and as of S. aureus, B. fragilis, P. an aid in the maintenance of weight melaninogenicus, F. necrophorum, and C. gains in the presence of bacterial en- perfringens. teritis and atrophic rhinitis. (3) Limitations. Federal law restricts (3) Limitations. Use as the sole source this drug to use by or on the order of a of chlortetracycline and sulfonamide. licensed veterinarian. Not to be used for more than 28 con- secutive days. Withdraw 15 days before [67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, slaughter. Federal law restricts this 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, drug to use by or on the order of a li- Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR censed veterinarian. 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; [76 FR 49649, Aug. 11, 2011, as amended at 81 81 FR 17607, Mar. 30, 2016] FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016] § 520.447 Clindamycin solution. (a) Specifications. Each milliliter of § 520.446 Clindamycin capsules and solution contains the equivalent of 25 tablets. milligrams (mg) clindamycin as the (a) Specifications. (1) Each capsule hydrochloride salt. contains the equivalent of 25, 75, 150, or (b) Sponsors. See Nos. 051311, 054771, 300 milligrams (mg) clindamycin as the 058829, 061623, and 069043 in § 510.600(c) of hydrochloride salt. this chapter.

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(c) Special considerations. Federal law 100 pounds body weight (0.8 micrograms restricts this drug to use by or on the per kilogram) for 3 days (6 treatments). order of a licensed veterinarian. If no improvement, administer 1 milli- (d) Conditions of use—(1) Dogs—(i) liter per 100 pounds (1.6 micrograms per Amount. Wounds, abscesses, and dental kilogram) for 3 days (6 treatments). If infections: 2.5 to 15 mg per pound (/lb) no improvement, administer 1.5 milli- body weight every 12 hours for a max- liters per 100 pounds (2.4 micrograms imum of 28 days. Osteomyelitis: 5.0 to per kilogram) for 3 days (6 treatments). 15 mg/lb body weight every 12 hours for If no improvement, administer 2.0 mil- a minimum of 28 days. liliters per 100 pounds (3.2 micrograms (ii) Indications for use. For the treat- per kilogram) for 3 days (6 treatments). ment of skin infections (wounds and If no improvement, horse is non- abscesses) due to susceptible strains of responder to clenbuterol and treatment coagulase-positive staphylococci should be discontinued. (Staphylococcus aureus or S. intermedius), deep wounds and abscesses (ii) Indications for use. Indicated for due to susceptible strains of Bacteroides the management of horses affected fragilis, Prevotella melaninogenicus, with airway obstruction, such as oc- Fusobacterium necrophorum, and Clos- curs in chronic obstructive pulmonary tridium perfringens; dental infections disease (COPD). due to susceptible strains of S. aureus, (iii) Limitations. Treat at effective B. fragilis, P. melaninogenicus, F. dose for 30 days. At the end of the 30- necrophorum, and C. perfringens; and os- day treatment period, drug should be teomyelitis due to susceptible strains withdrawn. If signs return, the 30-day of S. aureus, B. fragilis, P. treatment period may be repeated. If melaninogenicus, F. necrophorum, and C. repeating treatment, the step-wise dos- perfringens. age schedule should be repeated. The (2) Cats—(i) Amount. 5.0 to 15.0 mg/lb effect of this drug on breeding stallions body weight every 24 hours for a max- and brood mares has not been deter- imum of 14 days. mined. Treatment starting with dos- (ii) Indications for use. For the treat- ages higher than the initial dose is not ment of skin infections (wounds and recommended. Federal law prohibits abscesses) due to susceptible strains of the extralabel use of this drug in food Staphylococcus aureus, S. intermedius, animals. Federal law restricts this Streptococcus spp.; deep wounds and ab- drug to use by or on the order of a li- scesses due to susceptible strains of censed veterinarian. Clostridium perfringens and Bacteroides fragilis; and dental infections due to (2) [Reserved] susceptible strains of S. aureus, S. [63 FR 41419, Aug. 4, 1998] intermedius, Streptococcus spp., C. perfringens, and B. fragilis. § 520.455 Clomipramine tablets. [67 FR 54954, Aug. 27, 2002, as amended at 67 (a) Specifications. Each tablet con- FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, tains 5, 20, 40, or 80 milligrams (mg) 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, clomipramine hydrochloride. July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; (b) Sponsor. See No. 058198 in 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, § 510.600(c) of this chapter. 2016] (c) Conditions of use—(1) Amount. 2 to 4 milligrams of clomipramine hydro- § 520.452 Clenbuterol syrup. chloride per kilogram (0.9 to 1.8 milli- (a) Specifications. Each milliliter con- grams per pound) of body weight per tains 72.5 micrograms of clenbuterol day, administered as a single daily dose hydrochloride. or divided twice daily. (b) Sponsor. See 000010 in § 510.600(c) of (2) Indications for use. For use as part this chapter. of a comprehensive behavioral manage- (c) [Reserved] ment program to treat separation anx- (d) Conditions of use—(1) Horses—(i) iety in dogs greater than 6 months of Amount. Administer orally twice a day age. (b.i.d.). Initial dose is 0.5 milliliter per

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(3) Limitations. Federal law restricts (ii) Indications for use. For the control this drug to use by or on the order of a of atopic dermatitis in dogs weighing licensed veterinarian. at least 4 pounds. (iii) Limitations. Federal law restricts [64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007] this drug to use by or on the order of a licensed veterinarian. § 520.462 Clorsulon drench. (2) Cats. Use the solution described in paragraph (a)(2) of this section as fol- (a) Specifications. The drug is a sus- low: pension containing 8.5 percent (i) Amount. Administer 7 mg/kg of clorsulon (85 milligrams per milliliter). body weight orally as a single daily (b) Sponsor. See No. 050604 in dose for a minimum of 4 to 6 weeks or § 510.600(c) of this chapter. until resolution of clinical signs. Fol- (c) Conditions of use. Cattle—(1) lowing this initial daily treatment pe- Amount. One-quarter fluid ounce per 200 riod, the dosage may be tapered by de- pounds of body weight (7 milligrams creasing the frequency of administra- per kilogram or 3.2 milligrams per tion to every other day or twice weekly pound of body weight). to maintain the desired therapeutic ef- (2) Indications for use. For the treat- fect. ment of immature and adult liver fluke (ii) Indications for use. For the control (Fasciola hepatica) infestations in cat- of feline allergic dermatitis in cats at tle. least 6 months of age and weighing at (3) Limitations. Using dose syringe, least 3 pounds. deposit drench over back of tongue. Do (iii) Limitations. Federal law restricts not treat cattle within 8 days of this drug to use by or on the order of a slaughter. Because a withdrawal time licensed veterinarian. in milk has not been established, do not use in female dairy cattle of breed- [68 FR 54804, Sept. 19, 2003, as amended at 76 FR 78815, Dec. 20, 2011] ing age. Consult your veterinarian for assistance in the diagnosis, treatment, § 520.530 Cythioate oral liquid. and control of parasitism. (a) Specifications. Each milliliter con- [50 FR 10221, Mar. 14, 1985, as amended at 62 tains 15 milligrams of cythioate. FR 63270, Nov. 28, 1997] (b) Sponsor. See Nos. 000859 and 054771 in § 510.600 of this chapter. § 520.522 Cyclosporine. (c) Special considerations. Cythioate is (a) Specifications. (1) Each a cholinesterase inhibitor. Do not use cyclosporine capsule, USP (MODIFIED) this product in animals simultaneously contains 10, 25, 50, or 100 milligrams with or within a few days before or (mg) cyclosporine. after treatment with or exposure to (2) Each milliliter of cyclosporine cholinesterase-inhibiting drugs, insec- oral solution, USP (MODIFIED) con- ticides, pesticides, or chemicals. tains 100 mg cyclosporine. (d) Conditions of use—(1) Amount. 15 (b) Sponsor. See No. 058198 in milligrams cythioate per 10 pounds of § 510.600(c) of this chapter. body weight every third day or twice a (c) [Reserved] week. (d) Conditions of use—(1) Dogs. Use (2) Indications for use. Dogs, for con- capsules described in paragraph (a)(1) trol of fleas. of this section as follow: (3) Limitations. Federal law restricts (i) Amount. Administer 5 mg per kilo- this drug to use by or on the order of a gram (mg/kg) of body weight given licensed veterinarian. orally as a single daily dose for 30 days. [49 FR 5614, Feb. 14, 1984, as amended at 67 Following this initial daily treatment FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, period, the dosage may be tapered by 2014] decreasing the frequency of adminis- tration to every other day or two times § 520.531 Cythioate tablets. a week, until a minimum frequency is (a) Specifications. Each tablet con- reached which will maintain the de- tains 30 or 90 milligrams (mg) sired therapeutic effect. cythioate.

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(b) Sponsors. See sponsor numbers in (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for § 510.600(c) of this chapter as follows: 3 days, for use as in paragraph (d)(2)(ii) (1) No. 000859 for use of 30- and 90-mg of this section. tablets; (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for (2) No. 054771 for use of the 30-mg tab- up to 7 days, for use as in paragraph let. (d)(2)(iii) of this section. (c) Conditions of use—(1) Amount. 30 (2) Indications for use. (i) For the con- milligrams cythioate per 20 pounds of trol of pain and inflammation associ- body weight every third day or twice a ated with osteoarthritis. week. (ii) For the control of postoperative (2) Indications for use. Dogs, for con- pain and inflammation associated with trol of fleas. dental surgery. (3) Limitations. Federal law restricts this drug to use by or on the order of a (iii) For the control of postoperative licensed veterinarian. pain and inflammation associated with orthopedic surgery. [49 FR 5615, Feb. 14, 1984, as amended at 59 (3) Limitations. Federal law restricts FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, this drug to use by or on the order of a 2002; 79 FR 28819, May 20, 2014] licensed veterinarian. § 520.534 Decoquinate. [67 FR 68760, Nov. 13, 2002, as amended at 68 (a) Specifications. Each gram of pow- FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, der contains 8 milligrams (0.8 percent) 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, decoquinate. Jan. 26, 2012] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.540 Dexamethasone oral dosage (c) Related tolerances. See § 556.170 of forms. this chapter. § 520.540a Dexamethasone powder. (d) Conditions of use. Calves—(1) Amount. Feed 22.7 milligrams per 100 (a) Specifications. Each packet con- pounds of body weight (0.5 milligram tains 10 milligrams (mg) of dexametha- per kilogram) per day. sone. (2) Indications for use. For the preven- (b) Sponsor. See No. 000061 in tion of coccidiosis in ruminating and § 510.600(c) of this chapter. nonruminating calves, including veal (c) Conditions of use in cattle and calves, caused by Eimeria bovis and E. horses—(1) Amount. Administer 5 to 10 zuernii. mg per animal the first day then 5 mg (3) Limitations. Feed in whole milk at per day as required by drench or by the rate of 22.7 milligrams per 100 sprinkling on a small amount of feed. pounds body weight daily (0.5 milli- (2) Indications for use. As supportive gram per kilogram) for at least 28 days. therapy following parenteral steroid [64 FR 10103, Mar. 2, 1999, as amended at 64 administration for management or in- FR 30386, June 8, 1999; 79 FR 28819, May 20, flammatory conditions such as acute 2014] arthritic lameness, and for various stress conditions where corticosteroids § 520.538 Deracoxib. are required while the animal is being (a) Specifications. Each tablet con- treated for a specific condition. tains 12, 25, 50, 75, or 100 milligrams (3) Limitations. Federal law restricts (mg) deracoxib. this drug to use by or on the order of a (b) Sponsor. See No. 058198 in licensed veterinarian. A withdrawal pe- § 510.600(c) of this chapter. riod has not been established for this (c) [Reserved] (d) Conditions of use in dogs—(1) product in preruminating calves. Do Amount. Administer orally as needed, not use in calves to be processed for as a single daily dose based on body veal. Do not use in horses intended for weight: human consumption. (i) 1 to 2 mg/kilogram (kg) (0.45 to [79 FR 28819, May 20, 2014] 0.91 mg/pound (lb)), for use as in para- graph (d)(2)(i) of this section.

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§ 520.540b Dexamethasone tablets and divided doses until response is noted or boluses. 7 days have elapsed. When response is (a)(1) Specifications. Each bolus is attained, dosage should be gradually half-scored and contains 10 milligrams reduced by 0.125 milligram per day of dexamethasone. until maintenance level is achieved. (2) Sponsor. See No. 000061 in (2) Indications for use. As supportive § 510.600(c) of this chapter. therapy in nonspecific dermatosis and (3) Conditions of use in cattle and inflammatory conditions. horses—(i) Amount. Administer orally 5 (3) Limitations. Federal law restricts to 10 milligrams on the first day, then this drug to use by or on the order of a 5 milligrams per day as required. licensed veterinarian. (ii) Indications for use. As supportive [44 FR 7130, Feb. 6, 1979, as amended at 56 FR therapy following parenteral steroid 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 administration for management or in- FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, flammatory conditions such as acute 2017] arthritic lameness, and for various stress conditions where corticosteroids § 520.563 Dexamethasone chewable are required while the animal is being tablets. treated for a specific condition. (a) Specifications. Diatrizoate (iii) Limitations. Federal law restricts meglumine oral solution is a water this drug to use by or on the order of a soluble radiopaque medium containing licensed veterinarian. A withdrawal pe- 66 percent diatrizoate meglumine and riod has not been established for this 10 percent diatrizoate sodium. product in preruminating calves. Do (b) Sponsor. See No. 054771 in not use in calves to be processed for § 510.600(c) of this chapter. veal. Do not use in horses intended for (c) Conditions of use in dogs and cats— human consumption. (1) Amount. Administer orally 0.5 to 1.0 (b)(1) Specifications. Each tablet con- milliliter per pound of body weight by tains 0.25 milligram of dexamethasone. gavage or stomach tube. Administered (2) Sponsors. See Nos. 000061 and 061623 rectally 0.5 to 1.0 milliliter per pound in § 510.600(c) of this chapter. of body weight diluted with 1 part of (3) Conditions of use in dogs and cats— the drug to 5 parts of water. (i) Amount. Dogs: Administer orally 0.25 (2) Indications for use. For radiog- to 1.25 milligrams per day for up to 7 raphy of the gastrointestinal tract. days. Cats: Administer orally 0.125 to (3) Limitations. Federal law restricts 0.5 milligrams per day for up to 7 days. this drug to use by or on the order of a (ii) Indications for use. As an anti-in- licensed veterinarian. flammatory agent. (iii) Limitations. Federal law restricts [44 FR 12993, Mar. 9, 1979, as amended at 50 this drug to use by or on the order of a FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, licensed veterinarian. 2014] [40 FR 26273, June 23, 1975, as amended at 44 § 520.580 Dichlorophene and toluene. FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; (a) Specifications. Each capsule con- 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. tains 50 milligrams (mg) of 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, dichlorophene and 60 mg of toluene, or May 20, 2014] multiples thereof. (b) Sponsors. See sponsors in § 520.540c Dexamethasone chewable § 510.600(c) of this chapter for use as in tablets. paragraph (c) of this section: (a) Specifications. Each half-scored (1) Nos. 017135, 023851, 051311, and tablet contains 0.25 milligram of dexa- 058670 for use only as a single dose. methasone. (2) Nos. 000061 and 054771 for use in a (b) Sponsor. See No. 051031 in single dose or divided-dosage regimen. § 510.600(c) of this chapter. (c) Required statement. Consult your (c) Conditions of use in dogs—(1) veterinarian for assistance in the diag- Amount. Administer by free-choice nosis, treatment, and control of para- feeding or crumbled over food 0.25 to sitism, and before administering to 1.25 milligrams daily in single or two weak or debilitated animals.

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(d) Conditions of use—(1) Amount. Ad- (d) Related tolerances. See § 556.180 of minister as follows: this chapter. (i) Single dose: Administer 100 mg of (e) Conditions of use in swine. (1) It is dicholorophene and 120 mg of toluene recommended for the removal and con- per pound of body weight. trol of sexually mature (adult), sexu- (ii) Divided dose: Administer 100 mg ally immature and/or 4th stage larvae of dichlorophene and 120 mg of toluene of the whipworm (Trichuris suis), nod- per 5 pounds of body weight (20 and 24 ular worms (Oesophagostomum spp.), mg per pound) daily for 6 days. large round-worm (Ascaris suum), and (2) Indications for use. For the re- the mature thick stomach worm moval of ascarids (Toxocara canis and (Ascarops strongylina) occurring in the Toxascaris leonina) and hookworms lumen of the gastrointestinal tract of (Ancylostoma caninum and Uncinaria pigs, boars, and open or bred gilts and stenocephala); and as an aid in remov- sows. ing tapeworms (Taenia pisiformis, (2) The preparation should be added Dipylidium caninum, and Echinococcus to the indicated amount of feed as set granulosus) from dogs and cats. forth in paragraph (e)(2) of this section (3) Limitations. Withhold solid foods and administered shortly after mixing, and milk for at least 12 hours prior to as follows: medication and for 4 hours afterward. Pounds of Repeat treatment in 2 to 4 weeks in Pounds of mixed feed Number of feed to be to be admin- pigs to be animals subject to reinfection. Weight of ani- mixed with istered to treated per mal in pounds each 0.08 each pig as 0.08 ounce [45 FR 10332, Feb. 15, 1980] ounce of a single of dichlorvos dichlorvos treatment EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 520.580, see the List of CFR 20–30 ...... 4 0.33 12 Sections Affected, which appears in the 31–40 ...... 5 0.56 9 Finding Aids section of the printed volume 41–60 ...... 6 1.00 6 and at www.fdsys.gov. 61–80 ...... 5 1.00 5 81–100 ...... 4 1.00 4 Adult Gilts, § 520.581 Dichlorophene tablets. Sows, and (a) Specifications. Each tablet con- Boars ...... 16 4.00 4 tains 1 gram of dichlorophene. (b) Sponsor. See 023851 in § 510.600(c) of (3) Do not use this product on ani- this chapter. mals either simultaneously or within a (c) Required statement. Consult your few days before or after treatment with veterinarian for assistance in the diag- or exposure to cholinesterase inhib- nosis, treatment, and control of para- iting drugs, pesticides, or chemicals. sitism, and before administering to The preparation should be mixed thor- weak or debilitated animals. oughly with the feed on a clean, imper- (d) Conditions of use. Dogs—(1) vious surface. Do not allow swine ac- Amount. Single dose of 1 tablet (1 gram cess to feed other than that containing of dichlorophene) for each 10 pounds of the preparation until treatment is body weight. complete. Do not treat pigs with signs (2) Indications for use. It is used as an of scours until these signs subside or aid in the removal of tapeworms are alleviated by proper medication. (Taenia pisiformis and Dipylidium Resume normal feeding schedule after- caninum). wards. Swine may be retreated in 4 to (3) Limitations. Withhold solid foods 5 weeks. (f) Conditions of use in dogs. (1) For re- and milk for at least 12 hours prior to moval of Toxocara canis and Toxascaris medication and for 4 hours afterward. leonina (roundworms), Ancylostoma [45 FR 10333, Feb. 15, 1980] caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis § 520.600 Dichlorvos. (whipworm) residing in the lumen of (a) Chemical name. 2,2-Dichlorvinyl the gastrointestinal tract. dimethyl phosphate. (2) The drug is in capsule form for di- (b) [Reserved] rect administration and in pellet form (c) Sponsor. See No. 054628 in for administration in about one-third § 510.600(c) of this chapter. of the regular canned dog food ration

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or in ground meat. Dogs may be treat- milligrams to 18.5 milligrams per ed with any combination of capsules pound of body weight as a single dose. and/or pellets so that the animal re- It may be administered at one-half of ceives a single dose equaling 12 to 15 the single recommended dosage and re- milligrams of the active ingredient per peated 8 to 12 hours later in the treat- pound of body weight. One-half of the ment of very aged, emaciated or debili- single recommended dosage may be tated subjects or those reluctant to given, and the other half may be ad- consume medicated feed. In suspected ministered 8 to 24 hours later. This cases of severe ascarid infection suffi- split dosage schedule should be used in cient to cause concern over mechanical animals which are very old, heavily blockage of the intestinal tract, the parasitized, anemic, or otherwise de- split dosage should be utilized. bilitated. The drug should not be used (4) Do not use in horses which are se- in dogs weighing less than 2 pounds. verely debilitated, suffering from diar- (3) In some dogs, efficacy against rhea or severe constipation, infectious Trichurias vulpis (whipworm) may be er- disease, toxemia or colic. Do not ad- ratic. Dogs that do not develop a nega- minister in conjunction with or within tive stool for Trichuris vulpis ova 10 to 1 week of administration of muscle re- 14 days following initial treatment laxant drugs, phenothiazine derived should be re-treated. If a negative stool tranquilizers or central nervous system is not obtained in 10 to 14 days fol- depressant drugs. Horses should not be lowing re-treatment, alternate means subjected to insecticide treatment for 5 of therapy should be considered. days prior to or after treating with the (4) Do not use in dogs infected with drug. Do not administer to horses af- Dirofilaria immitis. flicted with chronic alveolar emphy- (5) Do not use with other sema (heaves) or related respiratory anthelmintics, taeniacides, antifilarial conditions. The product is a cholin- agents, muscle relaxants, or tranquil- esterase inhibitor and should not be izers. used simultaneously or within a few (6) The drug is a cholinesterase inhib- days before or after treatment with or itor. Not for use simultaneously or exposure to cholinesterase inhibiting within a few days before or after treat- drugs, pesticides or chemicals. ment with or exposure to cholin- esterase-inhibiting drugs, pesticides, or (5) Do not use in animals other than chemicals. horses, ponies, and mules. Do not use (7) Federal law restricts this drug to in horses, ponies, and mules intended use by or on the order of a licensed vet- for food purposes. Do not allow fowl ac- erinarian. cess to feed containing this preparation (g) Conditions of use in horses when ad- or to fecal excrement from treated ani- ministered in grain. (1) It is rec- mals. ommended for the removal and control (h) Conditions of use in horses when of bots (Gastrophilus intestinalis, G. na- administered orally by syringe. (1) It is salis), large strongyles (Strongylus recommended for the removal and con- vulgaris, S. equinus, S. edentatus), small trol of first, second, and third instar strongyles (of the genera bots (Gastrophilus intestinalis and G. na- Cyathostomum, Cylicocercus, salis), sexually mature and sexually im- Cylicocyclus, Cylicodontophorus, mature (4th stage) ascarids (Parascaris Triodontophorus, Poteriostomum, equorum) in horses and foals. Gyalocephalus), pinworms (Oxyuris (2) The product is in the form of a gel equi), and large roundworm (Parascaris which is administered directly from a equorum) in horses including ponies and syringe onto the horse’s tongue. The mules. Not for use in foals (sucklings product is administered at a dosage and young weanlings). level of 20 milligrams of dichlorvos per (2) For a satisfactory diagnosis, a mi- kilogram of body weight for the re- croscopic fecal examination should be moval of bots and ascarids. The same performed by a veterinarian or a diag- dosage level is repeated every 21 to 28 nostic laboratory prior to worming. days for the control of bots and (3) It is administered in the grain ascarids. For the control of bots only, portion of the ration at a dosage of 14.2 the repeat dosage is 10 milligrams per

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kilogram of body weight every 21 to 28 (9) Federal law restricts this drug to days during bot fly season. use by or on the order of a licensed vet- (3) Do not use this product in animals erinarian. simultaneously or within a few days [40 FR 13838, Mar. 27, 1975, as amended at 48 before or after treatment with or expo- FR 40704, Sept. 9, 1983; 51 FR 28546, Aug. 8, sure to cholinesterase-inhibiting drugs, 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, pesticides or chemicals. Do not admin- Apr. 15, 1999; 78 FR 21059, Apr. 9, 2013] ister in conjunction with or within 1 week of administration of muscle-re- § 520.606 Diclazuril. laxant drugs, phenothiazine derived (a) Specifications. Each 100 grams (g) tranquilizers, or central nervous sys- of pellets contain 1.56 g diclazuril. tem depressants. (b) Sponsor. See No. 000061 in (4) Do not use in horses which are § 510.600(c) of this chapter. severly debilitated or suffering from di- (c) Conditions of use in horses—(1) arrhea or severe constipation, infec- tious disease, toxemia, or colic. Do not Amount. Administer 1 milligram (mg) administer to horses affected with per kilogram (0.45 mg per pound) of chronic alveolar emphysema (heaves) body weight in the daily grain ration or other respiratory conditions. for 28 days. (5) Do not use in horses intended for (2) Indications for use. For the treat- food purposes. ment of equine protozoal (6) Federal law restricts this drug to myeloencephalitis (EPM) caused by use by or on the order of a licensed vet- Sarcocystis neurona. erinarian. (3) Limitations. Do not use in horses (i) Conditions of use in dogs, cats, pup- intended for human consumption. Fed- pies, and kittens. (1) Each tablet con- eral law restricts this drug to use by or tains 2, 5, 10, or 20 milligrams of on the order of a licensed veterinarian. dichlorvos. [72 FR 20943, Apr. 27, 2007] (2) It is administered orally at 5 mil- ligrams of dichlorvos per pound of body § 520.608 Dicloxacillin. weight. (a) Specifications. Each capsule con- (3) Dogs and puppies: Removal and tains dicloxacillin sodium control of intestinal roundworms monohydrate equivalent to 50, 100, 200, (Toxocara canis and Toxascaris leonina) or 500 milligrams of dicloxacillin. and hookworms (Ancylostoma caninum (b) Sponsor. See No. 054771 in § 510.600 and Uncinaria stenocephala). (c) of this chapter. (4) Cats and kittens: Removal and (c) Conditions of use in dogs—(1) control of intestinal roundworms Amount. Administer orally 5 to 10 milli- (Toxocara cati and Toxascaris leonina) grams per pound of body weight, three and hookworms (Ancylostoma times daily. In severe cases, up to 25 tubaeforme and Uncinaria stenocephala). milligrams per pound of body weight (5) Dichlorvos is a cholinesterase in- three times daily. hibitor. Do not use simultaneously (2) Indications for use. For the treat- with or within a few days before or ment of pyoderma (pyogenic derma- after treatment with or exposure to cholinesterase-inhibiting drugs, pes- titis) due to penicillinase-producing ticides, or chemicals. staphylococci sensitive to dicloxacillin. (6) Do not use in animals under 10 days of age or 1 pound of body weight. (3) Limitations. Federal law restricts (7) Do not administer to animals this drug to use by or on the order of a showing signs of constipation, mechan- licensed veterinarian. ical blockage of the intestinal tract, [57 FR 37325, Aug. 18, 1992, as amended at 79 impaired liver function, or recently ex- FR 28820, May 20, 2014] posed to or showing signs of infectious disease. (8) Do not use in dogs or puppies in- fected with Dirofilaria immitis.

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§ 520.620 Diethylcarbamazine oral dos- (2) Limitations. Federal law restricts age forms. this drug to use by or on the order of a licensed veterinarian. § 520.622 Diethylcarbamazine citrate oral dosage forms. [46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, § 520.622a Diethylcarbamazine citrate Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR tablets. 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; (a) Sponsors. (1) [Reserved] 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, (2) See 054771 in § 510.600(c) of this 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR chapter for use of 100, 200, and 300 milli- 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 gram tablets for prevention of heart- FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, worm disease in dogs and as an aid in 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, the treatment of ascarid infections in May 20, 2014] dogs. § 520.622b Diethylcarbamazine citrate (3) See 061623 in § 510.600(c) of this syrup. chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of (a)(1) Specifications. Each milliliter of heartworm disease in dogs, as an aid in syrup contains 60 milligrams of diethylcarbamazine citrate. the control of ascarid infections in (2) Sponsor. See No. 054771 in dogs, and as an aid in the treatment of § 510.600(c) of this chapter. ascarid infections in dogs and cats. (3) Conditions of use. (i) The drug is (4) [Reserved] indicated for use in dogs for the pre- (5) See No. 000061 in § 510.600(c) of this vention of infection with Dirofilaria chapter for use of 60, 120, or 180 milli- immitis and T. canis and T. leonina. It is gram tablets for prevention of heart- also indicated for treatment of ascarid worm disease in dogs, as an aid in the infections of T. canis and T. leonina in control of ascarid infections in dogs, dogs and T. cati in cats. and as an aid in the treatment of asca- (ii) For prevention of heartworm and rid infections in dogs and cats. ascarid infections in dogs, the drug (6) See No. 054628 in § 510.600(c) of this may be added to the daily diet at a dos- chapter for use of 50, 100, 200, 300, or 400 age rate of 3.0 milligrams per pound of milligram tablets for prevention of body weight per day or given directly heartworm disease in dogs, as an aid in by mouth at the same dosage rate. For the control of ascarid infections in treatment of ascarid infections in dogs dogs, and as an aid in the treatment of and cats, the drug is administered at a ascarid infections in dogs and cats. dosage level of 25 to 50 milligrams per pound of body weight preferably ad- (b) Conditions of use—(1) Dosage/indi- ministered immediately after feeding. cations for use. (i) Three milligrams per (iii) Older dogs should be proven neg- pound of body weight daily for preven- ative for the presence of Dirofilaria tion of heartworm disease (Dirofilaria immitis infection before administration immitis) in dogs. of the drug. Those with proven infec- (ii) Three milligrams per pound of tion of Dirofilaria immitis should be ren- body weight daily as an aid in the con- dered negative using adulticidal and trol of ascarid infections (Toxocara microfilaricidal drugs before adminis- canis) in dogs. tration of this drug. (iii) Twenty-five to 50 milligrams per (iv) Federal law restricts this drug to pound of body weight as an aid in the use by or on the order of a licensed vet- treatment of ascarid infections in dogs erinarian. (Toxocara canis) and cats (Toxocara (b) [Reserved] canis and Toxascaris leonina). (c)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate. (2) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (3) Conditions of use. (i) The drug is used in dogs between 4 weeks and 8

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months of age for the removal of (6) For 054628, use of 30, 60, 120, or 180 ascarids (Toxacara canis) and in ani- milligram tablets as in paragraph mals over 4 weeks of age for the pre- (c)(2)(i) of this section. vention of heartworm disease (c) Conditions of use—(1) Amount. 3 (Dirofilaria immitis). milligrams per pound of body weight (ii) The drug is administered (a) for per day for prevention of heartworm removal of ascarids at a dosage of 50 disease and control of ascarids; 25 to 50 milligrams per pound of body weight milligrams per pound of body weight as divided into two equal doses and ad- an aid in treatment of ascarid infec- ministered 8 to 12 hours apart (morning tions. and night), orally or mixed with either (2) Indications for use. (i) For preven- dry or wet food, and (b) for prevention tion of heartworm disease (Dirofilaria of heartworm disease at a dosage of 3 immitis) in dogs; as an aid in control of milligrams per pound of body weight ascarids (Toxocara canis) in dogs; as an daily, orally or in food, in heartworm aid in treatment of ascarid (Toxocara endemic areas, from the beginning of canis and Toxascaris leonina) infections mosquito activity, during the mosquito in dogs and cats. season, and for 2 months following the (ii) For prevention of infection with end thereof. Dirofilaria immitis (heartworm disease) (iii) Dogs older than 8 months of age in dogs; as an aid in treatment of asca- may be infected with Dirofilaria immitis. rid (Toxocara canis and Toxascaris Use of the drug is contraindicated in leonina) infections in dogs. dogs with active D. immitis infections. (iii) For prevention of heartworm dis- (iv) Federal law restricts this drug to ease (Dirofilaria immitis) in dogs. use by or on the order of a licensed vet- (3) Limitations. Federal law restricts erinarian. this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, [43 FR 6941, Feb. 17, 1978] 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, EDITORIAL NOTE: For FEDERAL REGISTER ci- Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR tations affecting § 520.622c, see the List of 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; CFR Sections Affected, which appears in the 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, Finding Aids section of the printed volume 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, and at www.fdsys.gov. Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014] § 520.623 Diethylcarbamazine and oxibendazole chewable tablets. § 520.622c Diethylcarbamazine citrate chewable tablets. (a) Specifications. Each tablet con- tains either 60, 120, or 180 milligrams of (a) Specifications. Each chewable tab- diethylcarbamazine citrate with 45, 91, let contains 30, 45, 60, 120, 150, or 180 or 136 milligrams of oxibendazole, re- milligrams of diethylcarbamazine cit- spectively. rate. (b) Sponsor. See No. 054771 in (b) Sponsors. See drug listing nos. in § 510.600(c) of this chapter. § 510.600(c) of this chapter for identi- (c) Conditions of use in dogs—(1) fication of sponsors as follows: Amount. Administer orally to dogs at a (1) [Reserved] dosage level of 6.6 milligrams of (2) For 054771, use of 60, 120, or 180 diethylcarbamazine citrate per kilo- milligram tablets as in paragraph gram of body weight (3 milligrams per (c)(2)(ii) of this section. pound of body weight) and 5.0 milli- (3) For 061690, use of 45 or 150 milli- grams of oxibendazole per kilogram of gram tablets as in paragraph (c)(2)(iii) body weight (2.27 milligrams per pound of this section. of body weight). (4) For 061133, use of 60-, 120-, or 180- (2) Indications for use. For prevention milligram tablets as in paragraph of infection with Dirofilaria immitis (c)(2)(i) of this section. (heartworm disease) and Ancylostoma (5) For 000061, use of 60-milligram caninum (hookworm infection) and for tablets as in paragraph (c)(2)(i) of this removal and control of Trichuris vulpis section. (whipworm infection) and mature and

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immature stages of intestinal Toxocara (3) Limitations. Federal law restricts canis (ascarid infection). this drug to use by or on the order of a (3) Limitations. Federal law restricts licensed veterinarian. this drug to use by or on the order of a [72 FR 263, Jan. 4, 2007, as amended at 79 FR licensed veterinarian. 28820, May 20, 2014]

[50 FR 28768, July 16, 1985, as amended at 53 § 520.763 Dithiazanine oral dosage FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, forms. 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR § 520.763a Dithiazanine tablets. 28820, May 20, 2014] (a) Specifications. Each tablet con- § 520.645 Difloxacin. tains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide. (a) Specifications. Each tablet con- (b) Sponsor. See No. 054628 in tains 11.4, 45.4, or 136 milligrams (mg) § 510.600(c) of this chapter. of difloxacin hydrochloride. (c) Conditions of use in dogs—(1) Indi- (b) Sponsor. See No. 000010 in cations for use and amount. Administer § 510.600(c) of this chapter. orally immediately after feeding as fol- (c) [Reserved] lows: (d) Conditions of use—(i) Amount. Ad- (i) For large roundworms (Toxocara minister 5 to 10 mg per kilogram (2.3 to canis, Toxascaris leonina): 10 mg per 4.6 mg per pound) of body weight orally pound (/lb) of body weight for 3 to 5 once a day for 2 to 3 days beyond ces- days; sation of clinical signs of disease up to (ii) For hookworms (Ancylostoma a maximum of 30 days. caninum, Uncinaria stenocephala) and (ii) Indications for use. For manage- whipworms (Trichuris vulpis): 10 mg/lb ment of diseases in dogs associated of body weight for 7 days; with bacteria susceptible to difloxacin. (iii) For Strongyloides (Strongyloides (iii) Limitations. Federal law prohibits canis, Strongyloides stercoralis): 10 mg/lb the extra-label use of this drug in food- of body weight for 10 to 12 days; producing animals. Federal law re- (iv) For heartworm microfilariae stricts this drug to use by or on the (Dirofilaria immitus): 3 to 5 mg/lb of order of a licensed veterinarian. body weight for 7 to 10 days. Treatment (2) [Reserved] for heartworm microfilariae should fol- low 6 weeks after therapy for adult [63 FR 8123, Feb. 18, 1998, as amended at 75 worms. FR 10165, Mar. 5, 2010] (2) Limitations. Federal law restricts this drug to use by or on the order of a § 520.666 Dirlotapide. licensed veterinarian. (a) Specifications. Each milliliter [79 FR 28820, May 20, 2014] (mL) of solution contains 5 milligrams (mg) dirlotapide. § 520.763b Dithiazanine powder. (b) Sponsor. See No. 054771 in (a) Specifications. Each tablespoon of § 510.600(c) of this chapter. powder contains 200 milligrams (mg) (c) Conditions of use in dogs—(1) dithiazanine iodide. Amount. The initial dosage is 0.01 mL/ (b) Sponsor. See No. 000010 in kg (0.0045 mL/lb) body weight for the § 510.600(c) of this chapter. first 14 days. After the first 14 days of (c) Conditions of use in dogs—(1) Indi- treatment, the dose volume is doubled cations for use and amount. Administer to 0.02 mL/kg (0.009 mL/lb) body weight orally by mixing in food as follows: for the next 14 days (days 15 to 28 of (i) For large roundworms (Toxocara treatment). Dogs should be weighed canis, Toxascaris leonina): 10 mg per monthly and the dose volume adjusted pound (/lb) of body weight for 3 to 5 every month, as necessary, to maintain days; a target percent weight loss until the (ii) For hookworms (Ancylostoma desired weight is achieved. caninum, Uncinaria stenocephala) and (2) Indications for use. For the man- whipworms (Trichuris vulpis): 10 mg/lb agement of obesity. of body weight for 7 days;

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(iii) For Strongyloides (Strongyloides (c) Conditions of use in horses—(1) canis, Strongyloides stercoralis): 10 mg/lb Amount. Administer 0.5 mg per pound of body weight for 10 to 12 days; (mg/lb) (1.1 mg/kilogram (kg)) by (iv) For heartworm microfilariae mouth once daily starting 10 to 15 days (Dirofilaria immitus): 3 to 5 mg/lb of prior to the expected foaling date. body weight for 7 to 10 days. Treatment Treatment may be continued for up to for heartworm microfilariae should fol- 5 days after foaling if mares are not low 6 weeks after therapy for adult producing adequate milk. worms. (2) Indications for use. For prevention (2) Limitations. Federal law restricts of fescue toxicosis in periparturient this drug to use by or on the order of a mares. licensed veterinarian. (3) Limitations. Do not use in horses [79 FR 28820, May 20, 2014] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.763c Dithiazanine iodide and pi- on the order of a licensed veterinarian. perazine citrate suspension. [75 FR 67031, Nov. 1, 2010] (a) Specifications. Each milliliter of suspension contains 69 milligrams (mg) § 520.784 Doxylamine. dithiazanine iodide and 83 mg piper- (a) Specifications. The drug is in tab- azine base (as piperazine citrate). let form and contains doxylamine suc- (b) Sponsor. See No. 054628 in cinate as the active drug ingredient. § 510.600(c) of this chapter. (b) Sponsor. See No. 000061 in (c) Conditions of use in horses—(1) § 510.600(c) of this chapter. Amount. 1 ounce (30 milliliters) per 100 (c) Conditions of use—(1) Amount. pounds of body weight for the first 500 Horses: Administer orally 1 to 2 milli- pounds; 3⁄4 ounce for each 100 pounds grams (mg) per pound (/lb) of body thereafter, up to 1,200 pounds; 101⁄4 weight per day divided into 3 or 4 equal ounces to animals over 1,200 pounds. doses. Dogs and cats: Administer orally (2) Indications for use. For control of 2 to 3 mg/lb of body weight per day di- large roundworms, Parascaris equorum; vided into 3 or 4 equal doses. small strongyles; large strongyles, Strongylus vulgaris; and pinworms, (2) Indications for use. For use when Oxyuris equi. antihistaminic therapy may be ex- pected to alleviate some signs of dis- (3) Limitations. Administer by drench ease in horses, dogs, and cats. or mixed with the daily ration as a sin- gle dose. Treatment is recommended in (3) Limitations. Do not use in horses spring and fall. In a heavily infested intended for human consumption. Fed- environment, treatment may be re- eral law restricts this drug to use by or peated every 30 days. Not for use in on the order of a licensed veterinarian. horses intended for food purposes. Se- [40 FR 13838, Mar. 27, 1975, as amended at 42 verely debilitated animals should not FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, be wormed except on the advice of a 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, veterinarian. If the drug is for adminis- Nov. 19, 1997; 79 FR 28821, May 20, 2014] tration by stomach tube, it shall be la- beled: ‘‘Federal law restricts this drug § 520.804 Enalapril. to use by or on the order of a licensed (a) Specifications. Each tablet con- veterinarian.’’ tains 1.0, 2.5, 5.0, 10, or 20 milligrams [47 FR 52696, Nov. 23, 1982, as amended at 48 (mg) of enalapril maleate. FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, (b) Sponsor. See No. 050604 in 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, § 510.600(c) of this chapter. Apr. 9, 2013; 79 FR 28820, May 20, 2014] (c) Conditions of use in dogs—(1) Amount. Administer orally 0.5 to 1.0 mg § 520.766 Domperidone. of enalapril maleate per kilogram of (a) Specifications. Each milliliter of body weight per day. gel contains 110 milligrams (mg) (2) Indications for use. For the treat- domperidone. ment of mild, moderate, and severe (b) Sponsor. See No. 043264 in § 510.600 (modified New York Heart Association of this chapter. Class II, III, IV) heart failure in dogs.

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(3) Limitations. Federal law restricts (ii) Indications for use. Removal of fe- this drug to use by or on the order of a line cestodes D. caninum and T. licensed veterinarian. taeniaeformis. (3) Limitations. Federal law restricts [79 FR 28821, May 20, 2014, as amended at 80 this drug to use by or on the order of a FR 34278, June 16, 2015] licensed veterinarian. § 520.812 Enrofloxacin. [54 FR 50615, Dec. 8, 1989, as amended at 56 (a) Specifications. Each tablet con- FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28821, May 20, 2014] tains: (1) 22.7, 68.0, or 136.0 milligrams (mg) § 520.823 Erythromycin. enrofloxacin; or (a) Specifications. Each gram of pow- (2) 22.7, 68.0, 136.0, or 272 mg der contains erythromycin phosphate enrofloxacin. equivalent to 0.89 gram of erythro- (b) Sponsors. See sponsor numbers in mycin master standard. § 510.600(c) of this chapter for use as in (b) Sponsor. See No. 061623 in paragraph (c) of this section. § 510.600(c) of this chapter. (1) Nos. 000859 and 026637 for use of (c) Related tolerances. See § 556.230 of product described in paragraph (a)(1) of this chapter. this section. (d) Conditions of use. It is used in (2) No. 058198 for use of product de- drinking water as follows: scribed in paragraph (a)(2) of this sec- (1) Broiler and replacement chickens— tion. (i) Amount. Administer 0.500 gram per (c) Conditions of use in dogs and cats— gallon for 5 days. (1) Amount. Administer orally as a sin- (ii) Indications for use. As an aid in gle, daily dose or divided into two the control of chronic respiratory dis- equal doses at 12-hour intervals. ease due to Mycoplasma gallisepticum (i) Dogs. 5 to 20 mg per kilogram (/kg) susceptible to erythromycin. (2.27 to 9.07 mg per pound (/lb)) of body (iii) Limitations. Do not use in re- weight. placement pullets over 16 weeks of age. Do not use in chickens producing eggs (ii) Cats. 5 mg/kg (2.27 mg/lb) of body for human consumption. Withdraw 1 weight. day before slaughter. Federal law re- (2) Indications for use. For the man- stricts this drug to use by or on the agement of diseases associated with order of a licensed veterinarian. bacteria susceptible to enrofloxacin. (2) Replacement chickens and chicken (3) Limitations. Federal law restricts breeders—(i) Amount. Administer 0.500 this drug to use by or on the order of a gram per gallon for 7 days. licensed veterinarian. Federal law pro- (ii) Indications for use. As an aid in hibits the extralabel use of this drug in the control of infectious coryza due to food-producing animals. Haemophilus gallinarum susceptible to [78 FR 30197, May 22, 2013, as amended at 78 erythromycin. FR 52853, Aug. 27, 2013] (iii) Limitations. Do not use in re- placement pullets over 16 weeks of age. § 520.816 Epsiprantel. Do not use in chickens producing eggs for human consumption. Withdraw 1 (a) Specifications. Each tablet con- day before slaughter. Federal law re- tains either 12.5, 25, 50, or 100 milli- stricts this drug to use by or on the grams of epsiprantel. order of a licensed veterinarian. (b) Sponsor. See No. 050604 in (3) Growing turkeys—(i) Amount. Ad- § 510.600(c) of this chapter. minister 0.500 gram per gallon for 7 (c) Conditions of use—(1) Dogs—(i) days. Amount. 2.5 milligrams per pound of (ii) Indications for use. As an aid in body weight. the control of blue comb (nonspecific (ii) Indications for use. Removal of ca- infectious enteritis) caused by orga- nine cestodes Dipylidium caninum and nisms susceptible to erythromycin. Taenia pisiformis. (iii) Limitations. Do not use in tur- (2) Cats—(i) Amount. 1.25 milligrams keys producing eggs for human con- per pound of body weight. sumption. Withdraw 1 day before

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slaughter. Federal law restricts this kilogram (4.5 to 6.8 mg per pound) of drug to use by or on the order of a li- body weight per day orally. censed veterinarian. (2) Indications for use. For the man- agement of pain and inflammation as- [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, sociated with osteoarthritis. 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, (3) Limitations. Federal law restricts May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR this drug to use by or on the order of a 94989, Dec. 27, 2016] licensed veterinarian. [63 FR 51300, Sept. 25, 1998, as amended at 68 § 520.852 Estriol. FR 51705, Aug. 28, 2003; 75 FR 10166, Mar. 5, (a) Specifications. Each tablet con- 2010; 79 FR 28821, May 20, 2014] tains 1 milligram (mg) estriol. (b) Sponsor. See No. 000061 in § 520.903 Febantel oral dosage forms. § 510.600(c) of this chapter. § 520.903a Febantel paste. (c) Conditions of use in dogs—(1) Amount. Administer at an initial dose (a) Specifications. Each gram of paste of 2 mg per dog per day. The dosage contains 455 milligrams (45.5 percent) may be titrated to as low as 0.5 mg per febantel. dog every second day, depending on re- (b) Sponsor. See No. 000859 in sponse. § 510.600(c) of this chapter. (2) Indications for use. For the control (c) Conditions of use in horses—(1) of estrogen-responsive urinary inconti- Amount. Administer paste orally at 6 nence in ovariohysterectomized female milligrams per kilogram (2.73 milli- dogs. grams per pound) of body weight on the (3) Limitations. Federal law restricts base of the tongue or well mixed into a this drug to use by or on the order of a portion of the normal grain ration. For licensed veterinarian. animals maintained on premises where reinfection is likely to occur, retreat- [76 FR 78150, Dec. 16, 2011] ment may be necessary. For most ef- fective results, retreat in 6 to 8 weeks. § 520.863 Ethylisobutrazine. (2) Indications for use. For removal of (a) Specifications. Each tablet con- large strongyles (Strongylus vulgaris, S. tains either 10 milligrams or 50 milli- edentatus, S. equinus); ascarids grams of ethylisobutrazine hydro- (Parascaris equorum—sexually mature chloride. and immature); pinworms (Oxyuris (b) Sponsor. See No. 000061 in equi—adult and 4th stage larva); and § 510.600(c) of this chapter. various small strongyles in horses, (c) Conditions of use in dogs—(1) foals, and ponies. Amount. Administer orally 2 to 5 milli- (3) Limitations. Do not use in horses grams per pound of body weight once intended for human consumption. Con- daily. sult your veterinarian for assistance in (2) Indications for use. As a tranquil- the diagnosis, treatment, and control izer. of parasitism. (3) Limitations. Federal law restricts [79 FR 28821, May 20, 2014] this drug to use by or on the order of a licensed veterinarian. § 520.903b Febantel suspension. [40 FR 13838, Mar. 27, 1975, as amended at 46 (a) Specifications. Each ounce of sus- FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; pension contains 2.75 grams (9.3 percent 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, ounce) febantel. 2014] (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. § 520.870 Etodolac. (c) Conditions of use in horses—(1) (a) Specifications. Each tablet con- Amount. 3 milliliters per 100 pounds tains 150, 300, or 500 milligrams (mg) of body weight or 1 fluid ounce per 1000 etodolac. pounds (6 milligrams per kilogram (b) Sponsor. See No. 000010 in body weight). Administer by stomach § 510.600(c) of this chapter. tube or drench, or by mixing well into (c) Conditions of use in dogs—(1) a portion of the normal grain ration. Amount. Administer 10 to 15 mg per For animals maintained on premises

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where reinfection is likely to occur, re- stenocephala), whipworms (Trichuris treatment may be necessary. For most vulpis), ascarids (Toxocara canis and effective results, retreat in 6 to 8 Toxascaris leonina), and tapeworms weeks. (Dipylidium caninum and Taenia (2) Indications for use. For removal of pisiformis). ascarids (Parascaris equorum—adult and (ii) Cats and kittens: For removal of sexually immature), pinworms (Oxyuris hookworms (Ancylostoma tubaeforme), equi—adult and 4th stage larvae), large ascarids (Toxocara cati) and tapeworms strongyles (Strongylus vulgaris, S. (Dipylidium caninum and Taenia edentatus, S. equinus), and various taeniaeformis). small strongyles in horses, breeding (3) Limitations. Federal law restricts stallions and mares, pregnant mares, this drug to use by or on the order of a foals, and ponies. licensed veterinarian. (3) Limitations. Do not use in horses [50 FR 19167, May 7, 1985, as amended at 53 intended for human consumption. Fed- FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; eral law restricts this drug to use by or 79 FR 28821, May 20, 2014] on the order of a licensed veterinarian. (d) Special considerations. Febantel § 520.903e Febantel tablets. suspension may be used in combination (a) Specifications. Each scored tablet with trichlorfon oral liquid in accord- contains 27.2 milligrams of febantel for ance with the provisions of § 520.2520c, use in dogs, puppies, cats, and kittens this section, and the following condi- or 163.3 milligrams of febantel for use tions: in dogs, puppies, and cats. (1) Combine 1 part febantel suspen- (b) Sponsor. See No. 000859 in sion with 5 parts trichlorfon liquid. § 510.600(c) of this chapter. (2) Allow animal to consume a por- (c) Conditions of use—(1) Amount—(i) tion of daily grain ration; administer Dogs and cats. Ten milligrams per kilo- mixture by stomach tube at rate of 18 gram body weight. Administer once milliliters per 100 pounds of body daily for 3 consecutive days. weight. (ii) Puppies and kittens fewer than 6 [45 FR 8587, Feb. 8, 1980, as amended at 79 FR months of age. Fifteen milligrams per 28821, May 20, 2014] kilogram body weight. Administer once daily for 3 consecutive days. § 520.903c [Reserved] (2) Indications for use. (i) For removal of hookworms (Ancylostoma caninum § 520.903d Febantel and praziquantel and Uncinaria stenocephala), ascarids paste. (Toxocara canis and Toxascaris leonina) (a) Specifications. Each gram of paste and whipworms (Trichuris vulpis) in contains 34 milligrams of febantel and dogs and puppies. 3.4 milligrams of praziquantel. (ii) For removal of hookworms (b) Sponsor. See No. 000859 in (Ancylostoma tubaeforme) and ascarids § 510.600(c) of this chapter. (Toxocara cati) in cats and kittens. (c) Conditions of use—(1) Amount—(i) (3) Limitations. Federal law restricts Dogs and cats (over 6 months of age): 10 this drug to use by or on the order of a milligrams of febantel and 1 milligram licensed veterinarian. of praziquantel per kilogram of body [56 FR 50655, Oct. 8, 1991, as amended at 79 FR weight (1 gram of paste per 7.5 pounds 28821, May 20, 2014] body weight) administered by mouth or in the food once daily for 3 days. § 520.905 Fenbendazole oral dosage (ii) Puppies and kittens (less than 6 forms. months of age): 15 milligrams of febantel and 1.5 milligrams of § 520.905a Fenbendazole suspension. praziquantel per kilogram of body (a) Specifications. Each milliliter of weight (1 gram of paste per 5 pounds suspension contains 100 milligrams body weight) administered by mouth (mg) fenbendazole for use as in para- on a full stomach once daily for 3 days. graphs (e)(1), (2), (3), and (4) of this sec- (2) Indications for use. (i) Dogs and tion; or 200 mg fenbendazole for use as puppies: For removal of hookworms in paragraphs (e)(5) and (6) of this sec- (Ancylostoma caninum and Uncinaria tion.

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(b) Sponsor. See No. 000061 in has not been established for this prod- § 510.600(c) of this chapter. uct in preruminating calves. Do not (c) Related tolerances. See § 556.275 of use in calves to be processed for veal. this chapter. (3) Beef cattle—(i) Amount. Administer (d) Special considerations. (1) See orally 10 mg/kg of body weight (2.3 mg/ § 500.25 of this chapter. lb). Retreatment may be needed after 4 (2) Fenbendazole suspension 10 per- to 6 weeks. cent and approved forms of trichlorfon, (ii) Indications for use. For the re- when used concomitantly for treating moval and control of stomach worm the indications provided in paragraph (4th stage inhibited larvae/type II (e) of this section and for treating in- ostertagiasis), Ostertagia ostertagi, and fections of stomach bot as provided in tapeworm, Moniezia benedeni. § 520.2520, have been shown to be com- (iii) Limitations. Cattle must not be patible and not to interfere with one slaughtered within 8 days following another. last treatment. A withdrawal period (e) Conditions of use—(1) Horses—(i) has not been established for this prod- Amount. Administer orally 5 mg per uct in preruminating calves. Do not kilogram (/kg) (2.3 mg per pound (/lb)) use in calves to be processed for veal. for the control of large strongyles, Federal law restricts this drug to use small strongyles, and pinworms; 10 mg/ by or on the order of a licensed veteri- kg for the control of ascarids. narian. (ii) Indications for use. For the control (4) Goats—(i) Amount. Administer of large strongyles (Strongylus orally 5 mg/kg of body weight (2.3 mg/ edentatus, S. equinus, S. vulgaris), small lb). Retreatment may be needed after 4 strongyles (Cyanthostomum spp., to 6 weeks. Cylicocyclus spp., Cylicostephanus spp., (ii) Indications for use. For the re- Triodontophorus spp.), pinworms moval and control of stomach worms (Oxyuris equi), and ascarids (Parascaris (adults) Haemonchus contortus and equorum) in horses. Teladorsagia circumcincta. (iii) Limitations. Administer by dose (iii) Limitations. Goats must not be syringe or suitable plastic syringe. Do slaughtered for food within 6 days fol- not use in horses intended for human lowing last treatment. Do not use in consumption. lactating goats. (2) Cattle including dairy cows of breed- (5) Chickens—(i) Amount. Administer ing age—(i) Amount. Administer orally 5 orally via drinking water at a daily mg/kg of body weight (2.3 mg/lb). Re- dose of 1 mg/kg body weight (0.454 mg/ treatment may be needed after 4 to 6 lb) for 5 consecutive days. weeks. (ii) Indications for use. For the treat- (ii) Indications for use. For the re- ment and control of adult Ascaridia moval and control of lungworm galli in broiler chickens and replace- (Dictyocaulus viviparus); stomach worm ment chickens intended to become (adults)—brown stomach worm breeding chickens, and for the treat- (Ostertagia ostertagi); stomach worms ment and control of adult A. galli and (adults and 4th-stage larvae)— Heterakis gallinarum in breeding chick- barberpole worm (Haemonchus contortus ens. and H. placei) and small stomach worm (iii) Limitations. Not for use in laying (Trichostongylus axei); intestinal worms hens and replacement chickens in- (adults and 4th-stage larvae)— tended to become laying hens. hookworm (Bunostonmum phlebotomum), (6) Swine, except for nursing piglets—(i) threadnecked intestinal worm Amount. Administer orally via the (Nematodirus helvetianus), small intes- drinking water at a daily dose of 2.2 tinal worm (Cooperia punctata and C. mg/kg of body weight (1.0 mg/lb) for 3 oncophora), bankrupt worm consecutive days. (Trichostrongylus colubriformis), and (ii) Indications for use. For the treat- nodular worm (Oesophagostomum ment and control of lungworms: Adult radiatum). Metastrongylus apri, adult M. (iii) Limitations. Cattle must not be pudendotectus; gastrointestinal worms: slaughtered within 8 days following Adult and larvae (L3, L4 stages, liver, last treatment. A withdrawal period lung, intestinal forms) large

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roundworms (Ascaris suum); nodular (iii) Limitations. Mix the appropriate worms (Oesophagostomum dentatum, O. amount of drug with a small amount of quadrispinulatum); small stomach the usual food; dry dog food may re- worms (Hyostrongylus rubidus): Adult quire slight moistening to facilitate and larvae (L2, L3, L4 stages—intes- mixing. Medicated food must be fully tinal mucosal forms) whipworms consumed. (Trichuris suis); and kidney worms: (3) Zoo and wildlife animals—(i) Adult and larvae Stephanurus dentatus. Amount. 10 mg/kg per day for 3 days. (iii) Limitations. Swine intended for (ii) Indications for use. For control of human consumption must not be internal parasites of Felidae and slaughtered within 2 days from the last Ursidae as follows: treatment. (A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid (Toxocara cati, [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. Toxascaris leonina), Hookworm 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, (Ancylostoma spp.). 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, (B) Cheetah (Acinonyx jubatus): Asca- Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR rid (Toxocara cati, Toxascaris leonina). 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; (C) Puma (Felis concolor), Panther 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. (Panthera spp.), Leopard (Panthera 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR pardus), Jaguar (Panthera onca): Asca- 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; rid (Toxocara cati, Toxascaris leonina), 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. Hookworm (Ancylostoma spp.), Tape- 29, 2011; 80 FR 76386, Dec. 9, 2015; 81 FR 22523, worm (Taenia hydatigena, T. krabbei, T. Apr. 18, 2016] taeniaeformis). § 520.905b Fenbendazole granules. (D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga, (a) Specifications. Each gram of gran- Toxascaris leonina), Hookworm ules contains 222 milligrams (mg) (Ancylostoma caninum), Tapeworm fenbendazole. (Taenia hydatigena, T. krabbei). (b) Sponsor. See No. 000061 in (E) Polar Bear (Ursus maritimus) and § 510.600(c) of this chapter. Grizzly Bear (Ursus horribilis): Ascarid (c) Special considerations. See § 500.25 (Baylisascaris transfuga, Toxascaris of this chapter. leonina). (d) Conditions of use—(1) Horses—(i) (iii) Limitations. Top dress or mix Amount. 5 mg/kilogram (kg) for large with a small portion of food. Must be strongyles, small strongyles, and fully consumed prior to feeding. Fed- pinworms; 10 mg/kg for ascarids. eral law restricts this drug to use by or (ii) Indications for use. For the control on the order of a licensed veterinarian. of infections of large strongyles Do not use 14 days before or during the (Strongylus edentatus, S. equinus, S. hunting season. vulgaris), small strongyles, pinworms [44 FR 1375, Jan. 5, 1979, as amended at 47 FR (Oxyuris equi), and ascarids (Parascaris 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 equorum). FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, (iii) Limitations. Sprinkle the appro- 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, priate amount of drug on a small Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] amount of the usual grain ration. Pre- pare for each horse individually. With- § 520.905c Fenbendazole paste. holding feed or water is not necessary. (a) Specifications. Each gram of paste Retreat in 6 to 8 weeks if required. Do contains 100 milligrams (mg) not use in horses intended for food. fenbendazole (10 percent). (2) Dogs—(i) Amount. 50 mg/kg daily (b) Sponsor. See No. 000061 in for 3 consecutive days. § 510.600(c) of this chapter. (ii) Indications for use. For the treat- (c) Related tolerances. See § 556.275 of ment and control of ascarids (Toxocara this chapter. canis, Toxascaris leonina), hookworms (d) Special considerations. See § 500.25 (Ancylostoma caninum, Uncinaria of this chapter. stenocephala), whipworms (Trichuris (e) Conditions of use—(1) Horses—(i) vulpis), and tapeworms (Taenia Indications for use and amounts—(A) For pisiformis). control of large strongyles (Strongylus

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edentatus, S. equinus, S. vulgaris), small (2) Each 4-ounce packet contains 1.7 strongyles, pinworms (Oxyuris equi), grams (1.5 percent) of fenbendazole plus and ascarids (Parascaris equorum): 2.3 other inert ingredients. mg per pound (/lb) of body weight, or (b) Sponsors. (1) See No. 000061 in for foals and weanlings (less than 18 § 510.600(c) of this chapter for use of the months of age), 4.6 mg/lb of body 4-percent product. weight. Retreatment at intervals of 6 (2) See No. 051311 in § 510.600(c) of this to 8 weeks may be required. chapter for use of the 1.5-percent prod- (B) For control of arteritis caused by uct. the fourth-stage larvae of S. vulgaris: (c) Related tolerances. See § 556.275 of 4.6 mg/lb of body weight daily for 5 this chapter. days. Treatment should be initiated in (d) Conditions of use. It is adminis- the spring and repeated in 6 months. tered to swine as follows: (1) Amount. 3 milligrams fenbendazole (C) For treatment of encysted per kilogram body weight per day (1.36 mucosal cyathostome (small strongyle) milligrams per pound per day). larvae including early third-stage (2) Indications for use. For removal (hypobiotic), late third-stage, and and control of large roundworms fourth-stage larvae: 4.6 mg/lb of body (Ascaris suum); lungworms weight daily for 5 consecutive days. (Metastrongylus apri); nodular worms (D) Fenbendazole paste 10 percent (Oesophagostomum dentatum, O. may be used concomitantly with ap- quadrispinulatum); small stomach proved forms of trichlorfon for the in- worms (Hyostrongylus rubidus); dications provided in paragraph whipworms (Trichuris suis); and (e)(1)(i)(A) of this section and for treat- kidneyworms (Stephanurus dentatus— ing infections of stomach bots as pro- mature and immature). vided in § 520.2520. (3) Limitations. Thoroughly mix the (ii) Limitations. Do not use in horses contents of the packet(s) with swine intended for human consumption. ration and administer according to (2) Cattle—(i) Amount. 2.3 mg/lb of label directions. Feed as sole ration for body weight. Retreatment may be 3 consecutive days. Can be fed to preg- needed after 4 to 6 weeks. nant sows. No prior withdrawal of feed (ii) Indications for use. For the re- or water is necessary. Consult your moval and control of lungworms veterinarian for assistance in the diag- (Dictyocaulus viviparus), stomach nosis, treatment, and control of para- worms (Haemonchus contortus, sitism. Ostertagia ostertagi, Trichostrongylus [49 FR 18090, Apr. 27, 1984, as amended at 49 axei), and intestinal worms FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, (Bunostomum phlebotomum, Nematodirus 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, helvetianus, Cooperia punctata, C. Nov. 25, 2009] oncophora, Trichostrongylus colubriformis, and Oesophagostomum § 520.905e Fenbendazole blocks. radiatum). (a) Specifications. (1) Each pound of (iii) Limitations. Cattle must not be molasses block contains 750 milligrams slaughtered within 8 days following of fenbendazole. last treatment. A withdrawal period (2) Each pound of protein block con- has not been established for this prod- tains 750 milligrams of fenbendazole. uct in preruminating calves. Do not (b) Sponsor. See 000061 in § 510.600(c) of use in calves to be processed for veal. this chapter. (c) Related tolerances. See § 556.275 of [72 FR 24185, May 2, 2007, as amended at 74 this chapter. FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, (d) Conditions of use—(1) Amount. 0.1 2011] pound of block per 100 pounds of body weight per day for 3 days. Total dose § 520.905d Fenbendazole powder. for the 3-day period is 2.27 milligrams (a) Specifications. (1) Each 2-ounce of fenbendazole per pound of body packet contains 2.27 grams (4 percent) weight for mature cattle. of fenbendazole plus other inert ingre- (2) Indications for use. For removal dients. and control of infections of lungworms

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(Dictyocaulus viviparus) and gastro- eral law restricts this drug to use by or intestinal roundworms (Haemonchus on the order of a licensed veterinarian. contortus, Ostertagia ostertagi, [69 FR 51171, Aug. 18, 2004, as amended at 73 Trichostrongylus axei, Bunostomum FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, phlebotomum, Nematodirus helvetianus, 2008; 81 FR 67151, Sept. 30, 2016] Cooperia oncophora and C. punctata, Trichostrongylus colubriformis, and § 520.930 Firocoxib paste. Oesophagostomum radiatum) in beef cat- (a) Specifications. Each milligram tle. (mg) of paste contains 0.82 mg (3) Limitations. Administer free choice firocoxib. of beef cattle on pasture that have be- (b) Sponsors. See No. 050604 in come accustomed to nonmedicated § 510.600(c) of this chapter. block feeding during an adaptation pe- (c) Conditions of use in horses—(1) riod of 12 to 19 days. Molasses block: Amount. 0.1 mg per kilogram (0.045 mg Cattle must not be slaughtered within per pound) body weight daily for up to 11 days following last treatment. Pro- 14 days. tein block: Cattle must not be slaugh- (2) Indications for use. For the control tered within 16 days following last of pain and inflammation associated treatment; do not use in dairy cattle of with osteoarthritis. breeding age. Animals maintained under conditions of constant worm ex- (3) Limitations. Do not use in horses posure may require retreatment within intended for human consumption. Fed- 6 to 8 weeks. Consult your veterinarian eral law restricts this drug to use by or for assistance in the diagnosis, treat- on the order of a licensed veterinarian. ment, and control of parasitism. [71 FR 5788, Feb. 3, 2006]

[51 FR 41783, Nov. 19, 1986, as amended at 54 § 520.955 Florfenicol. FR 20787, May 15, 1989; 66 FR 47960, Sept. 17, 2001; 74 FR 61516, Nov. 25, 2009] (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) § 520.928 Firocoxib tablets. florfenicol. (a) Specifications. Each chewable tab- (b) Sponsors. See Nos. 000061, 054925, let contains 57 or 227 milligrams (mg) and 058198 in § 510.600(c) of this chapter. firocoxib. (c) Related tolerances. See § 556.283 of (b) Sponsor. See No. 050604 in this chapter. § 510.600(c) of this chapter. (d) Conditions of use in swine—(1) (c) Conditions of use—(1) Dogs—(i) Amount. Administer in drinking water Amount. 5 mg/kg (2.27 mg/lb) body ad libitum at 400 mg per gallon (100 weight. Administer once daily for os- parts per million (ppm)) for 5 consecu- teoarthritis. Administer approximately tive days. 2 hours before soft tissue or orthopedic (2) Indications for use. For the treat- surgery. ment of swine respiratory disease (ii) Indications for use. For the control (SRD) associated with Actinobacillus of pain and inflammation associated pleuropneumoniae, Pasteurella multocida, with osteoarthritis; and for the control Salmonella choleraesuis and Strepto- of postoperative pain and inflamma- coccus suis. tion associated with soft-tissue and or- (3) Limitations. Do not slaughter with- thopedic surgery. in 16 days of last treatment. Federal (iii) Limitations. Federal law restricts law restricts this drug to use by or on this drug to use by or on the order of a the order of a licensed veterinarian. licensed veterinarian. [67 FR 78357, Dec. 24, 2002, as amended at 72 (2) Horses—(i) Amount. Administer FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013; one 57-mg tablet to horses weighing 800 82 FR 12169, Mar. 1, 2017] to 1,300 lb once daily for up to 14 days. (ii) Indications for use. For the control § 520.960 Flumethasone. of pain and inflammation associated (a) Specifications. Each tablet con- with osteoarthritis. tains 0.0625 milligram of flumethasone. (iii) Limitations. Do not use in horses (b) Sponsor. See No. 054771 in intended for human consumption. Fed- § 510.600(c) of this chapter.

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(c) Conditions of use—(1) Amount—(i) (c) Conditions of use in dogs—(1) Dogs: Administer orally from 0.0625 to Amount. 1 to 2 mg per kilogram body 0.25 milligram daily in divided doses. weight once daily. (ii) Cats: Administer orally from (2) Indications for use. For the treat- 0.03125 to 0.125 milligram daily in di- ment of canine separation anxiety in vided doses. conjunction with a behavior modifica- (2) Indications for use—(i) Dogs: It is tion plan. used for musculoskeletal conditions (3) Limitations. Federal law restricts due to inflammation of muscles or this drug to use by or on the order of a joints and accessory structures, where licensed veterinarian. permanent structural changes do not [72 FR 6463, Feb. 12, 2007, as amended at 79 exist, such as arthritis, the disc syn- FR 74020, Dec. 15, 2014] drome, and myositis. (ii) Dogs and cats: It is used in certain § 520.998 Fluralaner. acute and chronic dermatoses of vary- (a) Specifications. Each chewable tab- ing etiology to help control the pru- let contains 112.5, 250, 500, 1000, or 1400 ritus, irritation, and inflammation as- milligrams (mg) fluralaner. sociated with these conditions. (b) Sponsor. See No. 000061 in (3) Limitations. Federal law restricts § 510.600(c) of this chapter. this drug to use by or on the order of a (c) Conditions of use in dogs—(1) licensed veterinarian. Amount. Administer orally as a single [44 FR 7131, Feb. 6, 1979, as amended at 61 FR dose every 12 weeks according to the 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014] label dosage schedule to provide a min- imum dose of 11.4 mg per pound (/lb) (25 § 520.970 Flunixin. mg per kilogram) body weight. May be (a) Specifications. (1) Each 10-gram (g) administered every 8 weeks in case of packet of granules contains flunixin potential exposure to Amblyomma meglumine equivalent to 250 milli- americanum ticks. grams (mg) of flunixin. (2) Indications for use. Kills adult (2) Each 30-g syringe of paste con- fleas; for the treatment and prevention tains flunixin meglumine equivalent to of flea infestations (Ctenocephalides 1,500 mg of flunixin. felis), and the treatment and control of (b) Sponsors. See sponsors in tick infestations [Ixodes scapularis § 510.600(c) of this chapter for use as in (black-legged tick), Dermacentor paragraph (c) of this section. variabilis (American dog tick), and (1) No. 000061 for use of products de- Rhipicephalus sanguineus (brown dog scribed in paragraph (a). tick)] for 12 weeks in dogs and puppies (2) No. 061623 for use of the product 6 months of age and older, and weigh- described in paragraph (a)(2). ing 4.4 lb or greater; for the treatment (c) Conditions of use in horses—(1) and control of A. americanum (lone star Amount. 0.5 mg per pound of body tick) infestations for 8 weeks in dogs weight per day for up to 5 days. and puppies 6 months of age and older, (2) Indications for use. For alleviation and weighing 4.4 lb or greater. of inflammation and pain associated (3) Limitations. Federal law restricts with musculoskeletal disorders. this drug to use by or on the order of a (3) Limitations. Do not use in horses licensed veterinarian. intended for human consumption. Fed- [79 FR 37619, July 2, 2014] eral law restricts this drug to use by or on the order of a licensed veterinarian. § 520.1010 Furosemide. [76 FR 53051, Aug. 25, 2011, as amended at 79 (a) Specifications. (1) Each tablet con- FR 74020, Dec. 15, 2014] tains 12.5 or 50 milligrams (mg) furosemide. § 520.980 Fluoxetine. (2) Each bolus contains 2 grams (g) (a) Specifications. Each chewable tab- furosemide. let contains 8, 16, 32, or 64 milligrams (3) Each packet of powder contains 2 (mg) fluoxetine hydrochloride. g furosemide. (b) Sponsor. See No. 050929 in § 510.600 (4) Each milliliter of syrup contains of this chapter. 10 mg furosemide.

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(b) Sponsors. See sponsor numbers in ciency and acute noninflammatory tis- § 510.600(c) of this chapter for use of sue edema. dosage forms and strengths listed in [66 FR 47960, Sept. 17, 2001, as amended at 69 paragraph (a) of this section for uses as FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, in paragraph (d) of this section. 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, (1) No. 000010 for tablets in paragraph Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR (a)(1) of this section for conditions of 17607, Mar. 30, 2016] use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section. § 520.1044 Gentamicin sulfate oral dos- (2) No. 000061 for tablets in paragraph age forms. (a)(1) of this section for conditions of § 520.1044a Gentamicin sulfate oral so- use in paragraphs (d)(2)(i), (d)(2)(ii)(A), lution. and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and (a) Specifications. Each milliliter of powder in paragraph (a)(3) of this sec- aqueous solution contains gentamicin tion for conditions of use in paragraph sulfate equivalent to 50 milligrams of (d)(1) of this section; and for syrup in gentamicin. paragraph (a)(4) of this section for con- (b) Sponsor. See Nos. 000061 and 054925 ditions of use in paragraphs (d)(2)(i) in § 510.600(c) of this chapter. and (d)(2)(ii)(A). (c) Related tolerances. See § 556.300 of (3) Nos. 058829 and 069043 for use of this chapter. syrup in paragraph (a)(4) of this section (d) Conditions of use—(1) Amount. for conditions of use in paragraph Colibacillosis: 1 milliliter per 2 gallons (d)(2)(i) and (d)(2)(ii)(A) of this section. of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/ (c) Special considerations. Federal law day; swine dysentery: 1 milliliter per 1 restricts this drug to use by or on the gallon of drinking water for 3 consecu- order of a licensed veterinarian. tive days, to provide 1.0 milligram/ (d) Conditions of use. It is used as fol- pound/day. lows: (2) Indications for use. In weanling (1) Cattle—(i) Amount. 1 to 2 mg per swine for control and treatment of pound (/lb) body weight using powder, colibacillosis caused by strains of E. or one 2-g bolus per animal, per day. coli sensitive to gentamicin, and in (ii) Indications for use. For treatment swine for control and treatment of of physiological parturient edema of swine dysentery associated with the mammary gland and associated Treponema hyodysenteriae. structures. (3) Limitations. Do not slaughter (iii) Limitations. Treatment not to ex- treated swine for food for at least 3 ceed 48 hours post-parturition. Milk days following treatment. Federal law taken during treatment and for 48 restricts this drug to use by or on the hours after the last treatment must order of a licensed veterinarian. not be used for food. Cattle must not be slaughtered for food within 48 hours [48 FR 10302, Mar. 11, 1983. Redesignated at 49 following last treatment. FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; (2) Dogs—(i) Amount. 1 to 2 mg/lb body 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. weight, once or twice daily. 16, 2006; 81 FR 94989, Dec. 27, 2016] (ii) Indications for use—(A) For treat- ment of edema (pulmonary congestion, § 520.1044b Gentamicin sulfate pig ascites) associated with cardiac insuffi- pump oral solution. ciency and acute noninflammatory tis- (a) Specifications. Each milliliter of sue edema. pig pump oral solution contains (B) For treatment of edema (pul- gentamicin sulfate equivalent to 4.35 monary congestion, ascites) associated milligrams of gentamicin. with cardiac insufficiency. (b) Sponsor. See Nos. 000061 and 016592 (3) Cats—(i) Amount. 1 to 2 mg/lb body in § 510.600(c) of this chapter. weight, once or twice daily. (c) Related tolerances. See § 556.300 of (ii) Indications for use. For treatment this chapter. of edema (pulmonary congestion, asci- (d) Conditions of use—(1) Amount. Ad- tes) associated with cardiac insuffi- minister 1.15 milliliters of pig pump

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oral solution (5 milligrams of use by or on the order of a licensed vet- gentamicin) orally per pig one time. erinarian. (2) Indications for use. In neonatal [77 FR 4226, Jan. 27, 2012, as amended at 81 swine 1 to 3 days of age for control and FR 94989, Dec. 27, 2016] treatment of colibacillosis caused by strains of E. coli sensitive to § 520.1060 Glucose and glycine. gentamicin. (a) Specifications. Each packet of pow- (3) Limitations. For use in neonatal der contains 8.82 grams sodium chlo- swine only. Do not slaughter treated ride, 4.20 grams potassium phosphate, swine for food for at least 14 days fol- 0.5 gram citric acid anhydrous, 0.12 lowing treatment. gram potassium citrate, 6.36 grams aminoacetic acid (glycine), and 44.0 [49 FR 572, Jan. 5, 1984, as amended at 52 FR grams glucose. 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; (b) Sponsor. See No. 054771 in 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18, 2016] § 510.600(c) of this chapter. (c) Conditions of use in calves—(1) § 520.1044c Gentamicin sulfate powder. Amount. Dissolve each packet in 2 quarts of warm water and administer (a) Specifications. Each gram of pow- to each calf as follows: der contains gentamicin sulfate equiv- (i) Scouring and/or dehydrated calves. alent to: Feed 2 quarts of solution, twice daily (1) 16.7, 66.7, or 333.3 milligrams (mg) for 2 days (four feedings). No milk or gentamicin. milk replacer should be fed during this (2) 333.3 mg gentamicin. period. For the next four feedings (days (b) Sponsors. See sponsors in 3 and 4), use 1 quart of solution to- § 510.600(c) of this chapter for use as in gether with 1 quart of milk replacer. paragraph (d) of this section as follows: Thereafter, feed as normal. (1) No. 000061 for products described (ii) Newly purchased calves. Feed 2 in paragraph (a)(1) of this section. quarts of solution instead of milk as (2) Nos. 057561 and 061623 for product the first feed upon arrival. For the next described in paragraph (a)(2) of this scheduled feeding, use 1 quart of solu- section. tion mixed together with 1 quart of milk or milk replacer. Thereafter, feed (c) Related tolerances. See § 556.300 of as normal. this chapter. (2) Indications for use. For control of (d) Conditions of use in swine—(1) dehydration associated with diarrhea Amount. Administer in drinking water (scours); and as an early treatment at for 3 consecutive days as follows: the first signs of scouring. It may also (i) For colibacillosis: Gentamicin sul- be used as followup treatment fol- fate equivalent to 25 mg of gentamicin lowing intravenous fluid therapy. per gallon of drinking water to provide (3) Limitations. The product should 0.5 mg per pound of body weight per not be used in animals with severe de- day; hydration (down, comatose, or in a (ii) For swine dysentery: Gentamicin state of shock). Such animals need in- sulfate equivalent to 50 mg of travenous therapy. A veterinarian gentamicin per gallon of drinking should be consulted in severely scour- water to provide 1 mg per pound of ing calves. The product is not nutri- body weight per day. Treatment may tionally complete if administered by be repeated if dysentery recurs. itself for long periods of time. It should (2) Indications for use. For control and not be administered beyond the rec- treatment of colibacillosis in weanling ommended treatment period without swine caused by strains of Escherichia the addition of milk or milk replacer. coli sensitive to gentamicin, and for [79 FR 28821, May 20, 2014] control and treatment of swine dys- entery associated with Treponema § 520.1084 Grapiprant. hyodysenteriae. (a) Specifications. Each tablet con- (3) Limitations. Withdrawal period: 10 tains 20, 60, or 100 milligrams (mg) days. Federal law restricts this drug to grapiprant.

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(b) Sponsor. See No. 086026 in grams; for animals weighing 18 to 36 § 510.600(c) of this chapter. pounds: 250 milligrams; for animals (c) Conditions of use in dogs—(1) weighing 36 to 48 pounds: 375 milli- Amount. Administer 0.9 mg/lb (2 mg/kg) grams; for animal weighing 48 to 75 once daily by mouth. pounds: 500 milligrams. (2) Indications for use. For the control (B) Weekly (single) dose: If experi- of pain and inflammation associated ence indicates that treatment is more with osteoarthritis in dogs. effective for the drug given in large (3) Limitations. Federal law restricts doses, administer at intervals of 7 to 10 this drug to use by or on the order of a days, a dose equal to 10 milligrams/ licensed veterinarian. pound of body weight × body weight × [81 FR 36789, June 8, 2016] number of days between treatments. Dosage should be adjusted according to § 520.1100 Griseofulvin. response. Administer additional dose (a) Specifications—(1) The powder after the animal is free of infection. complies with U.S.P. for griseofulvin, (ii) Indications for use. For treatment microsize. of fungal infections of the skin, hair, (2) Each bolus contains 2.5 grams and claws caused by Trichophyton griseofulvin. mentagrophytes, T. rubrum, T. (3) Each tablet contains 125 or 500 schoenleini, T. sulphurem, T. verrucosum, milligrams griseofulvin. T. interdigitale, Epidermophyton (b) Sponsors. See sponsors in floccosum, Microsporum gypseum, M. § 510.600(c) of this chapter. canis, M. audouini. (1) No. 000061 for use of products de- [40 FR 13838, Mar. 27, 1975, as amended at 41 scribed in paragraph (a) for use as in FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, paragraph (d) of this section. 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, (2) No. 061623 for use of the powder de- July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR scribed in paragraph (a)(1) for use as in 28253, May 14, 2012; 78 FR 28822, May 20, 2014] paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section. § 520.1120 Haloxon oral dosage forms. (c) Special considerations. Federal law § 520.1120a Haloxon drench. restricts this drug to use by or on the order of a licensed veterinarian. (a) Specifications. Each packet con- (d) Conditions of use—(1) Horses—(i) tains 141.5 grams haloxon. Amount and indications for use—(A) For (b) Sponsor. See No. 000061 in equine ringworm infection caused by § 510.600(c) of this chapter. Trichophyton equinum or Microsporum (c) Special considerations. Do not use gypseum, administer soluble powder de- any drug, insecticide, pesticide, or scribed in paragraph (a)(1) of this sec- other chemical having cholinesterase- tion daily as a drench or as a top dress- inhibiting activity either simulta- ing on feed for not less than 10 days as neously or within a few days before or follows: adults, 2.5 grams; yearlings, after treatment with haloxon. 1.25 to 2.5 grams; and foals, 1.25 grams. (d) Related tolerances. See § 556.310 of (B) For treating ringworm infection this chapter. caused by T. equinum, administer (e) Conditions of use in cattle—(1) boluses described in paragraph (a)(2) of Amount. Dissolve each packet in 32 this section daily for not less than 10 fluid ounces of water and administer as days as follows: adults, 1 bolus; year- follows: For animals weighing up to 100 lings, one-half to 1 bolus; and foals, pounds: 1⁄2 fluid ounce; for animals one-half bolus. weighing 100 to 150 pounds: 3⁄4 fluid (ii) Limitations. Do not use in horses ounce; for animals weighing 150 to 200 intended for human consumption. pounds: 1 fluid ounce; for animals (2) Dogs and cats: (i) Amount. 125- and weighing 200 to 300 pounds: 1 1⁄2 fluid 500-milligram tablets administered ounces; for animals weighing 300 to 450 orally as follows: pounds: 2 fluid ounces; for animals (A) Daily (single or divided) dose as weighing 450 to 700 pounds: 3 fluid follows: For animals weighing up to 6 ounces; for animals weighing 700 to pounds: 62.5 milligrams; for animals 1,000 pounds: 4 fluid ounces; for animals weighing 6 to 18 pounds: 125 milli- weighing 1,000 to 1,200 pounds: 5 fluid

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ounces; for animals weighing over 1,200 (2) Indications for use. For the treat- pounds: 6 fluid ounces. Retreat in 3 to ment of respiratory tract infections, 4 weeks. urinary tract infections, gastro- (2) Indications for use. For control of intestinal infections, skin infections, gastrointestinal roundworms of the soft tissue infections, and postsurgical genera Haemonchus, Ostertagia, infections associated with strains of or- Trichostrongylus, and Cooperia. ganisms susceptible to hetacillin po- (3) Limitations. Do not treat dairy tassium. animals of breeding age. Do not treat (3) Limitations. Federal law restricts within 1 week of slaughter. this drug to use only by or on the order [40 FR 13838, Mar. 27, 1975, as amended at 45 of a licensed veterinarian. FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, [75 FR 10166, Mar. 5, 2010] 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 78 FR 28822, May 20, 2014] § 520.1156 Imidacloprid. § 520.1120b Haloxon boluses. (a) Specifications. Each chewable tab- (a) Specifications. Each bolus contains let contains 7.5 or 37.5 milligrams (mg) 10.1 grams of haloxon. imidacloprid. (b) Sponsor. See No. 000061 in (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.310 of (c) Conditions of use in dogs—(1) this chapter. Amount. Administer daily one 7.5-mg (d) Conditions of use in cattle—(1) chewable tablet to dogs weighing 4 to Amount. Administered one bolus per 500 22 pounds (lb) or one 37.5-mg chewable pounds body weight (35 to 50 milli- table to dogs weighing 23 to 110 lb. grams per kilogram of body weight). (2) Indications for use. Kills adult fleas Retreat in 3 to 4 weeks. and is indicated for the treatment of (2) Indications for use. For control of flea infestations on dogs and puppies 10 gastrointestinal roundworms of the weeks of age and older and weighing 4 genera Haemonchus, Ostertagia, lb or greater. Trichostrongylus, and Cooperia. (3) Limitations. Do not give to puppies (3) Limitations. Do not treat dairy younger than 10 weeks of age or to dogs animals of breeding age or older. Do weighing less than 4 lb. Do not give not treat within 1 week of slaughter. more than one tablet a day. [40 FR 13838, Mar. 27, 1975, as amended at 44 [80 FR 18775, Apr. 8, 2015] FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, § 520.1157 Iodinated casein. Nov. 19, 1997; 78 FR 28822, May 20, 2014] (a) Specifications. Each 1-gram tablet § 520.1130 Hetacillin. contains 25 milligrams of iodinated ca- sein. (a) Specifications. (1) Each capsule or (b) Sponsor. See No. 017762 in tablet contains hetacillin potassium § 510.600(c) of this chapter. equivalent to 50, 100, or 200 milligrams (c) Conditions of use—(1) Amount. 1⁄5 to (mg) of ampicillin. 1 tablet per 10 pounds of body weight (2) Each milliliter of suspension con- (equivalent to 0.5 to 2.5 milligrams of tains hetacillin potassium equivalent iodinated casein per pound of body to 50 mg of ampicillin. weight). (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (2) Indications for use. For dogs for ap- (c) Conditions of use in dogs and cats— parent decreased thyroid activity (1) Amount—(i) Dogs. Administer 5 mg where the signs are alopecia, scaliness per pound (/lb) of body weight orally, of the skin surface, loss of hair, sebor- twice daily. In severe infections, ad- rhea, thickening of the skin, minister 5 mg/lb three times daily, or hyperpigmentation, and lethargy. up to 10 mg/lb twice daily. For stub- (3) Limitations. Federal law restricts born urinary tract infections, admin- this drug to use by or on the order of a ister up to 20 mg/lb twice daily. licensed veterinarian. (ii) Cats. Administer 50 mg twice [49 FR 22469, May 30, 1984, as amended at 78 daily. FR 28822, May 20, 2014]

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§ 520.1158 Iodochlorhydroxyquin. percent) or 0.00153 mg (0.153 percent) of ivermectin. (a) Specifications. Each bolus contains (b) Sponsors. See sponsors in 10 grams of iodochlorhydroxyquin. § 510.600(c) of this chapter for use as in (b) Sponsor. See No. 054771 in § 510.600 paragraph (e) of this section: (c) of this chapter. (1) No. 050604 for use of a 1.87 percent (c) Conditions of use—(1) Amount. 1 paste as in (e)(1) of this section and a bolus (10 grams) daily for a 1,000-pound 0.153 percent paste for use as in para- horse. graph (e)(2) of this section. (2) Indications for use. For treatment (2) Nos. 000859, 051311, 054925, and of equine diarrhea. 061623 for use of a 1.87 percent paste for (3) Limitations. Do not use in horses use as in paragraph (e)(1) of this sec- intended for human consumption. Fed- tion. eral law restricts this drug to use by or (c) Related tolerances. See § 556.344 of on the order of a licensed veterinarian. this chapter. [48 FR 8054, Feb. 25, 1983, as amended at 50 (d) Special considerations. See § 500.25 FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, of this chapter. 2014] (e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram § 520.1182 Iron dextran suspension. (91 micrograms per pound) of body (a) Specifications. Each milliliter weight. (mL) of suspension contains 55.56 milli- (ii) Indications for use. For treatment grams (mg) iron as ferric hydroxide in and control of Large Strongyles complex with a low molecular weight (adults): Strongylus vulgaris (also early dextran. forms in blood vessels), S. edentatus (b) Sponsor. See No. 051311 in (also tissue stages), S. equinus, § 510.600(c) of this chapter. Triodontophorus spp. including T. (c) Conditions of use in swine—(1) brevicauda and T. serratus, and Amount. Administer 100 mg (1.8 mL) Craterostomum acuticaudatum; Small orally by automatic dose dispenser. Strongyles (adults, including those re- (2) Indications for use. For the preven- sistant to some benzimidazole class tion of iron deficiency anemia in baby compounds): Coronocyclus spp. includ- pigs. ing C. coronatus, C. labiatus, and C. (3) Limitations. Treat each pig within labratus, Cyathostomum spp. including 24 hours of farrowing. C. catinatum and C. pateratum, [70 FR 32489, June 3, 2005] Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. § 520.1189 Itraconazole. brevicapsulatus, Cylicodontophorus spp., spp. including (a) Specifications. Each milliliter Cylicostephanus C. (mL) of solution contains 10 milligrams calicatus, C. goldi, C. longibursatus, and (mg) of itraconazole. C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. Pinworms (adults and fourth-stage lar- vae): ; Ascarids (adults and (c) Conditions of use—(1) Amount. Ad- Oxyuris equi minister 5 mg/kilogram (kg) (0.5 mL/ third- and fourth-stage larvae): kg) of body weight once daily on alter- Parascaris equorum; Hairworms (adults): nating weeks for 3 treatment cycles. Trichostrongylus axei; Large mouth Stomach Worms (adults): (2) Indications for use. For the treat- Habronema ment of dermatophytosis caused by muscae; Bots (oral and gastric stages): spp. including Microsporum canis in cats. Gasterophilus G. and ; Lungworms (3) Limitations. Federal law restricts intestinalis G. nasalis this drug to use by or on the order of a (adults and fourth-stage larvae): licensed veterinarian. Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides [82 FR 12169, Mar. 1, 2017] westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous § 520.1192 Ivermectin paste. third-stage larvae; Dermatitis caused (a) Specifications. Each milligram by neck threadworm microfilariae, (mg) of paste contains 0.0187 mg (1.87 Onchocerca sp.

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(iii) Limitations. For oral use only. Do (d) Conditions of use—(1) Dogs. For use not use in horses intended for human in dogs 6 weeks of age and older as fol- consumption. lows: (2) Cattle—(i) Amount. 23 milligrams (i) Amount. 6.0 mcg per kilogram (kg) per 250 pounds of body weight. of body weight (2.72 mcg per pound (ii) Indications for use. It is used in (lb)), minimum. Up to 25 lb, 68 mcg; 26 cattle for the treatment and control of to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; gastrointestinal roundworms (adults over 100 lb, a combination of the appro- and fourth-stage larvae) (Ostertagia priate tablets. Administer at monthly ostertagi (including inhibited forms), O. dosing intervals. lyrata, Haemonchus placei, (ii) Indications for use. To prevent ca- Trichostrongylus axei, T. colubriformis, nine heartworm disease by eliminating Cooperia oncophora, C. punctata, the tissue stage of heartworm larvae Nematodirus helvetianus, Bunostomum (Dirofilaria immitis) for 1 month (30 phlebotomum, Strongyloides papillosus days) after infection. (adults only), Oesophagostomum (2) Cats. For use in cats 6 weeks of radiatum, Trichuris ovis (adults only)); age and older as follows: lungworms (adults and fourth-stage (i) Amount. Up to 2.3 kilograms (up to larvae) (Dictyocaulus viviparus); grubs 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to (first, second, and third instars) 15 lb), 165 mcg; over 6.8 kilograms (15 (Hypoderma bovis, H. lineatum); and lb), a combination of the appropriate sucking lice (Linognathus vituli, chewables (recommended minimum Haematopinus eurysternus). dose of 24 mcg/kg of body weight (10.9 (iii) Limitations. For oral use only. Do mcg/lb)). Administer once a month. not treat cattle within 24 days of slaughter. Because withdrawal time in (ii) Indications for use. To prevent fe- milk has not been established, do not line heartworm disease by eliminating use in female dairy cattle of breeding the tissue stage of heartworm larvae age. Dirofilaria immitis for a month (30 days) after infection, and for removal and [49 FR 22275, May 29, 1984, as amended at 50 control of adult and immature (L4) FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, hookworms Ancylostoma tubaeforme and 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, A. braziliense. Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; [67 FR 11230, Mar. 13, 2002, as amended at 67 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, FR 21996, May 2, 2002; 69 FR 43735, July 22, 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, 2004; 81 FR 17607, Mar. 30, 2016] Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013] § 520.1194 Ivermectin meal. § 520.1193 Ivermectin tablets and (a) Specifications. Each gram of meal chewables. contains 6 milligrams ivermectin (0.6 (a) Specifications. (1) Each tablet or percent). chewable contains 68, 136, or 272 (b) Sponsor. See No. 017135 in micrograms (mcg) ivermectin. § 510.600(c) of this chapter. (2) Each chewable contains 55 or 165 (c) Special considerations. See § 500.25 mcg ivermectin. of this chapter. (b) Sponsors. See sponsors in (d) Conditions of use in horses—(1) § 510.600(c) of this chapter for use as in Amount. Administer 136 micrograms paragraph (d) of this section. (mcg) ivermectin per pound (/lb) body (1) No. 050604 for use of tablets or weight (300 mcg/kilogram) as a single chewables described in paragraph (a)(1) dose on approximately 2 lb grain or as in paragraph (d)(1) and chewables de- sweet feed. scribed in paragraph (a)(2) as in para- (2) Indications for use. For treatment graph (d)(2) of this section. and control of Large Strongyles (2) Nos. 051311 and 069043 for use of (adults): Strongylus vulgaris (also early tablets described in paragraph (a)(1) as forms in blood vessels), S. edentatus in paragraph (d)(1) of this section. (also tissue stages), S. equinus, (c) Special considerations. Federal law Triodontophorus spp. including T. restricts this drug to use by or on the brevicauda and T. serratus, and order of a licensed veterinarian. Craterostomum acuticaudatum; Small

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Strongyles (adults, including those re- (d) Special considerations. See § 500.25 sistant to some benzimidazole class of this chapter. compounds): Coronocyclus spp. includ- (e) Conditions of use—(1) Horses—(i) ing C. coronatus, C. labiatus, and C. Amount. 200 micrograms (mcg) per kilo- labratus, Cyathostomum spp. including gram (/kg) of body weight as a single C. catinatum and C. pateratum, dose by stomach tube or as an oral Cylicocyclus spp. including C. insigne, C. drench. leptostomum, C. nassatus, and C. (ii) Indications for use. For treatment brevicapsulatus, Cylicodontophorus spp., and control of: Cylicostephanus spp. including C. (A) Large Strongyles (adults): calicatus, C. goldi, C. longibursatus, and Strongylus vulgaris (also early forms in C. minutus, and Petrovinema poculatum; blood vessels), S. edentatus (also tissue Small Strongyles (fourth-stage larvae); stages), S. equinus, Triodontophorus spp. Pinworms (adults and fourth stage lar- including T. brevicauda and T. serratus, vae): Oxyuris equi; Ascarids (adults and and Craterostomum acuticaudatum; third- and fourth-stage larvae): Small Strongyles (adults, including Parascaris equorum; Hairworms (adults): those resistant to some benzimidazole Trichostrongylus axei; Large Mouth class compounds): Coronocyclus spp. in- Stomach Worms (adults): Habronema cluding C. coronatus, C. labiatus, and C. muscae; Bots (oral and gastric stages): labratus, Cyathostomum spp. including Gasterophilus spp. including G. C. catinatum and C. pateratum, intestinalis and G. nasalis; Lungworms Cylicocyclus spp. including C. insigne, C. (adults and fourth-stage larvae): leptostomum, C. nassatus, and C. Dictyocaulus arnfieldi; Intestinal brevicapsulatus, Cylicodontophorus spp., Threadworms (adults): Strongyloides Cylicostephanus spp. including C. westeri; Summer Sores caused by calicatus, C. goldi, C. longibursatus, and Habronema and Draschia spp. cutaneous C. minutus, and Petrovinema poculatum; third-stage larvae; Dermatitis caused Small Strongyles (fourth-stage larvae); by neck threadworm microfilariae, Pinworms (adults and fourth stage lar- Onchocerca sp. vae): Oxyuris equi; Ascarids (adults and Limitations. Do not use in horses in- third- and fourth-stage larvae): tended for human consumption. Parascaris equorum; Hairworms (adults): [70 FR 1817, Jan. 11, 2005, as amended at 70 Trichostrongylus axei; Large mouth FR 19262, Apr. 13, 2005] Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): § 520.1195 Ivermectin liquid. Gasterophilus spp. including G. (a) Specifications—(1) Each milliliter intestinalis and G. nasalis; Lungworms (mL) contains 10 milligrams (mg) (adults and fourth-stage larvae): ivermectin. Dictyocaulus arnfieldi; Intestinal (2) Each mL of micellar solution con- Threadworms (adults), Strongyloides tains 0.8 mg ivermectin. westeri; Summer Sores caused by (b) Sponsors. See sponsor numbers in Habronema and Draschia spp. cutaneous § 510.600(c) of this chapter. third-stage larvae; Dermatitis caused (1) Nos. 000859, 050604, 054925, and by neck threadworm microfilariae, 058005 for use of product described in Onchocerca sp. paragraph (a)(1) of this section as in (B) Large Strongyles (Strongylus paragraphs (e)(1)(i), (e)(1)(ii)(A), and equinus (adult), S. vulgaris (adult and (e)(1)(iii) of this section. arterial larval stages), S. endentatus (2) No. 058829 for use of product de- (adult and migrating tissue stages), scribed in paragraph (a)(1) of this sec- Triodontophorus spp. (adult)); Small tion as in paragraphs (e)(1)(i), Strongyles including those resistant to (e)(1)(ii)(B), and (e)(1)(iii) of this sec- some benzimidazole class compounds tion. (Cyathostomum spp. (adult and fourth- (3) Nos. 050604 and 058829 for use of stage larvae), Cylicocyclus spp., product described in paragraph (a)(2) of Cylicodontophorus spp., Cylicostephanus this section as in paragraph (e)(2) of spp.); Pinworms (Oxyuris equi (adult this section. and fourth-stage larvae)); Ascarids (c) Related tolerances. See § 556.344 of (Parascaris equorum (adult and third- this chapter. and fourth-stage larvae)); Hairworms

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(Trichostongylus axei ( adult)); Large of ivermectin and 5 mg of pyrantel per mouth Stomach Worms (Habronema kilogram (2.72 μg and 2.27 mg per muscae (adult)); Stomach Bots pound) of body weight monthly. (Gastrophilus spp. (oral and gastric (ii) Indications for use. To prevent ca- stages)); Lungworms (Dictyocaulus nine heartworm disease by eliminating arnfieldi (adult and fourth-stage lar- the tissue larval stages of Dirofilaria vae)); intestinal threadworms immitis for up to a month (30 days) after (Strongyloides westeri (adult)); Summer infection and treatment and control of Sores caused by Habronema and adult ascarids Toxocara canis and Draschia spp. cutaneous third-stage lar- Toxascaris leonina, and adult vae; and Dermatitis caused by neck hookworms Ancylostoma caninum, A. threadworm microfilariae (Onchocerca braziliense, and Uncinaria stenocephala. spp.). (iii) Limitations. Federal law restricts (iii) Limitations. Do not use in horses this drug to use by or on the order of a intended for human consumption. Fed- licensed veterinarian. eral law restricts this drug to use by or (2) [Reserved] on the order of a licensed veterinarian. [58 FR 8542, Feb. 16, 1993, as amended at 61 (2) Sheep—(i) Amount. 200 mcg/kg (3 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, mL/26 pounds) of body weight as a sin- 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, gle dose oral drench. July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR (ii) Indications for use. For treatment 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014] and control of the adult and fourth- stage larvae of gastrointestinal § 520.1197 Ivermectin sustained-re- roundworms (Haemonchus contortus, H. lease bolus. placei (adults only), Ostertagia (a) Specifications. Each sustained-re- circumcincta, Trichostrongylus axei, T. lease bolus contains 1.72 grams of colubriformis, Cooperia oncophora ivermectin. (adults only), C. curticei, (b) Sponsor. See No. 050604 in Oesophagostomum columbianum, O. § 510.600(c) of this chapter. venulosum (adults only), Nematodirus (c) Related tolerances. See § 556.344 of battus, N. spathiger, S. papillosus (adults this chapter. only), Chabertia ovina (adult only), (d) Conditions of use in ruminating Trichuris ovis (adults only)); lungworms calves—(1) Amount. Administer one (D. filaria); and all larval stages of the bolus per calf weighing at least 275 nasal bot Oestrus ovis. pounds (lb) (125 kilograms (kg)) and not (iii) Limitations. For use in sheep more than 660 lb (300 kg) on the day of only. Do not use in other animal spe- administration. cies as severe adverse reactions, in- (2) Indications. For treatment and cluding fatalities in dogs, may result. control, throughout the grazing season Do not treat sheep within 11 days of (approximately 130 days), of gastro- slaughter. intestinal roundworms Haemonchus placei, Ostertagia ostertagi (including in- [67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, hibited fourth-stage larvae), 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. Trichostrongylus axei, T. colubriformis, 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Cooperia spp., Nematodirus helvetianus, Feb. 27, 2014] Bunostomum phlebotomum, Oesophagostomum radiatum; lungworms § 520.1196 Ivermectin and pyrantel Dictyocaulus viviparus; grubs Hypoderma tablets. spp.; sucking lice Linognathus vituli, (a) Specifications. Each chewable tab- Solenopotes capillatus; mange mites let contains either 68 micrograms (μg) Psoroptes ovis, Sarcoptes scabiei, and of ivermectin and 57 milligrams (mg) of ticks Amblyomma americanum. pyrantel (as pamoate salt), or 136 μg (3) Limitations. The bolus was specifi- and 114 mg, or 272 μg and 227 mg, re- cally designed for use in cattle; do not spectively. use in other animal species. Calves (b) Sponsors. See Nos. 050604, 051311, must be ruminating and older than 12 and 063604 in § 510.600(c) of this chapter. weeks of age. Do not administer to (c) Conditions of use—(1) Dogs—(i) calves weighing less than 275 lb (125 Amount. Administer a minimum of 6 μg kg). Do not administer a damaged

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bolus. Because a milk withdrawal time and Craterostomum acuticaudatum; has not been established, do not use in Small Strongyles (adults, including female dairy cattle of breeding age. Do those resistant to some benzimidazole not slaughter cattle within 180 days of class compounds)—Coronocyclus spp. in- treatment. Consult your veterinarian cluding C. coronatus, C. labiatus, and C. for assistance in the diagnosis, treat- labratus; Cyathostomum spp. including ment, and control of parasitism. C. catinatum and C. pateratum; [61 FR 67452, Dec. 23, 1996, as amended at 62 Cylicocyclus spp. including C. insigne, C. FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, leptostomum, C. nassatus, and C. 2000] brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. § 520.1198 Ivermectin and praziquantel calicatus, C. goldi, C. longibursatus, and paste. C. minutus, and Petrovinema poculatum; (a) Specifications. Each milligram Small Strongyles—fourth-stage larvae; (mg) of paste contains: Pinworms (adults and fourth-stage lar- (1) 0.0155 mg (1.55 percent) ivermectin vae)—Oxyuris equi; Ascarids (adults and and 0.0775 mg (7.75 percent) third- and fourth-stage larvae)— praziquantel. Parascaris equorum; Hairworms (2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) (adults)—Trichostrongylus axei; Large- praziquantel. mouth Stomach Worms (adults)— (3) 0.0187 mg (1.87 percent) ivermectin Habronema muscae; Bots (oral and gas- and 0.2338 mg (23.38 percent) tric stages)—Gasterophilus spp. includ- praziquantel. ing G. intestinalis and G. nasalis; (b) Sponsors. See sponsors in Lungworms (adults and fourth-stage § 510.600(c) of this chapter for uses as in larvae)—Dictyocaulus arnfieldi; Intes- paragraph (d) of this section.— tinal Threadworms (adults)— (1) No. 050604 for use of product de- Strongyloides westeri; Summer Sores scribed in paragraph (a)(1) of this sec- caused by Habronema and Draschia spp. tion as in paragraphs (d)(1)(i), (d)(2)(i) cutaneous third-stage larvae; Derma- and (d)(3) of this section. titis caused by neck threadworm (2) No. 051311 for use of product de- microfilariae of Onchocerca sp. scribed in paragraph (a)(2) of this sec- (ii) For treatment and control of the tion as in paragraphs (d)(1)(ii), following parasites: Tapeworms— (d)(2)(ii), and (d)(3) of this section. Anoplocephala perfoliata; Large (3) No. 050604 for use of products de- Strongyles (adults)—Strongylus vulgaris scribed in paragraph (a)(3) of this sec- (also early forms in blood vessels), S. tion as in paragraphs (d)(1)(iii), edentatus (also tissue stages), S. (d)(2)(iii) and (d)(3) of this section. equinus, Triodontophorus spp.; Small (c) Special considerations. See § 500.25 Strongyles (adults, including those re- of this chapter. sistant to some benzimidazole class (d) Conditions of use in horses—(1) compounds)—Cyathostomum spp.; Amount—(i) 200 micrograms (mcg) per Cylicocyclus spp.; Cylicostephanus spp., kilogram (/kg) ivermectin (91 mcg per Cylicodontophorus spp.; Small pound (/lb)) and 1 mg/kg praziquantel Strongyles—fourth-stage larvae; (454 mcg/lb) body weight. (ii) 200 mcg/kg ivermectin (91 mcg/lb) Pinworms (adults and fourth-stage lar- and 1.5 mg/kg praziquantel (681 mcg/lb) vae)—Oxyuris equi; Ascarids (adults and body weight. third- and fourth-stage larvae)— (iii) 200 mcg/kg ivermectin (91 mcg/lb) Parascaris equorum; Hairworms and 2.5 mg/kg praziquantel (1.14 mg/lb). (adults)—Trichostrongylus axei; Large- (2) Indications for use—(i) For treat- mouth Stomach Worms (adults)— ment and control of the following Habronema muscae; Bots (oral and gas- parasites: Tapeworms—Anoplocephala tric stages)—Gasterophilus spp.; perfoliata; Large Strongyles (adults)— Lungworms (adults and fourth-stage Strongylus vulgaris (also early forms in larvae)—Dictyocaulus arnfieldi; Intes- blood vessels), S. edentatus (also tissue tinal Threadworms (adults)— stages), S. equinus, Triodontophorus spp. Strongyloides westeri; Summer Sores including T. brevicauda and T. serratus, caused by Habronema and Draschia spp.

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cutaneous third-stage larvae; Derma- (3) 136 mcg ivermectin, 114 mg titis caused by neck threadworm pyrantel pamoate, and 114 mg microfilariae, Onchocerca sp. praziquantel; or (iii) For treatment and control of the (4) 272 mcg ivermectin, 228 mg following parasites in horses over 5 pyrantel pamoate, and 228 mg months of age: Tapeworms— praziquantel. Anoplocephala perfoliata; Large (b) Sponsor. See No. 051311 in Strongyles (adults)—Strongylus vulgaris § 510.600(c) of this chapter. (also early forms in blood vessels), S. (c) Conditions of use in dogs—(1) edentatus (also tissue stages), S. Amount. Administer monthly according equinus, Triodontophorus spp. including to body weight as follows: T. brevicauda and T. serratus, and (i) 6 to 12 lb: one tablet as described Craterostomum acuticaudatum; Small in paragraph (a)(1) of this section. Strongyles (adults, including those re- (ii) 12.1 to 25 lb: one tablet as de- sistant to some benzimidazole class scribed in paragraph (a)(2) of this sec- compounds)—Coronocyclus spp. includ- tion. ing C. coronatus, C. labiatus, and C. (iii) 25.1 to 50 lb: one tablet as de- labratus; Cyathostomum spp. including scribed in paragraph (a)(3) of this sec- C. catinatum and C. pateratum; tion. Cylicocyclus spp. including C. insigne, C. (iv) 50.1 to 100 lb: one tablet as de- leptostomum, C. nassatus, and C. scribed in paragraph (a)(4) of this sec- brevicapsulatus; Cylicodontophorus spp.; tion. Cylicostephanus spp. including C. (v) Greater than 100 lb: use the appro- calicatus, C. goldi, C. longibursatus, and priate combination of tablets. C. minutus, and Petrovinema poculatum; (2) Indications for use. Prevents ca- Small Strongyles—fourth-stage larvae; nine heartworm disease by eliminating Pinworms (adults and fourth-stage lar- the tissue stage of heartworm larvae vae)—Oxyuris equi; Ascarids (adults and (Dirofilaria immitis) for 1 month (30 third- and fourth-stage larvae)— days) after infection and for the treat- Parascaris equorum; Hairworms ment and control of roundworm (adults)—Trichostrongylus axei; Large- (Toxocara canis, Toxascaris leonina), mouth Stomach Worms (adults)— hookworm (Ancylostoma caninum, Habronema muscae; Bots (oral and gas- Uncinaria stenocephala, Ancylostoma tric stages)—Gasterophilus spp. includ- braziliense) and tapeworm (Dipylidium ing G. intestinalis and G. nasalis; caninum, Taenia pisiformis) infections. Lungworms (adults and fourth-stage (3) Limitations. Federal law restricts larvae)—Dictyocaulus arnfieldi; Intes- this drug to use by or on the order of a tinal Threadworms (adults)— licensed veterinarian. Strongyloides westeri; Summer Sores [71 FR 65052, Nov. 7, 2006, as amended at 78 caused by Habronema and Draschia spp. FR 28822, May 20, 2014] cutaneous third-stage larvae; Derma- titis caused by neck threadworm § 520.1200 Ivermectin, fenbendazole, microfilariae of Onchocerca sp. and praziquantel tablets. (3) Limitations. For oral use only. Do (a) Specifications. Each chewable tab- not use in horses intended for human let contains either: consumption. (1) 68 micrograms (μg) ivermectin, [68 FR 55309, Sept. 25, 2003, as amended at 69 1.134 grams fenbendazole, and 57 milli- FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, grams (mg) praziquantel; or 2005; 79 FR 37619, July 2, 2014] (2) 27 μg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel. § 520.1199 Ivermectin, pyrantel, and (b) Sponsor. See No. 000061 in praziquantel tablets. § 510.600(c) of this chapter. (a) Specifications. Each chewable tab- (c) Conditions of use in dogs—(1) let contains: Amount. Administer tablets to provide (1) 34 micrograms (mcg) ivermectin, 6 μg per kilogram (/kg) ivermectin, 100 28.5 milligrams (mg) pyrantel pamoate, mg/kg fenbendazole, and 5 mg/kg and 28.5 mg praziquantel; praziquantel. (2) 68 mcg ivermectin, 57 mg pyrantel (2) Indications for use. For the treat- pamoate, and 57 mg praziquantel; ment and control of adult Toxocara

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canis (roundworm), Ancylostoma (e)(1)(ii)(B), and (e)(1)(iii) of this sec- caninum (hookworm), Trichuris vulpis tion; for 11.7-, 46.8-, and 544.5-g pack- (whipworm), and Dipylidium caninum ages as in paragraph (e)(2)(i), (tapeworm), and for the prevention of (e)(2)(ii)(B), and (e)(2)(iii) of this sec- heartworm disease caused by Dirofilaria tion; and for an 18.15-g package as in immitis in adult dogs. paragraph (e)(3) of this section. (3) Limitations. Federal law restricts (2) No. 054771 for use of a 46.8-g pack- this drug to use by or on the order of a age as in paragraph (e)(1)(i), licensed veterinarian. (e)(1)(ii)(A), and (e)(1)(iii) of this sec- [73 FR 33692, June 13, 2008, as amended at 74 tion; for 11.7- and 46.8-g packages as in FR 61516, Nov. 25, 2009] paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- § 520.1204 Kanamycin, bismuth subcar- and 18.15-g packages as in paragraph bonate, activated attapulgite. (e)(3) of this section. (a) Specifications—(1) Each 5 milli- (3) No. 057561 for use of 46.8- and 544.5- liters (mL) of suspension contains 100 g packages as in paragraphs (e)(1)(i), milligrams (mg) kanamycin (as the (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), sulfate), 250 mg bismuth subcarbonate, (e)(2)(ii)(A), and (e)(2)(iii) of this sec- and 500 mg activated attapulgite (alu- tion. minum magnesium silicate). (4) No. 059130 for use of 46.8-, 362.7-, (2) Each tablet contains 100 mg and 544.5-g packages as in paragraphs kanamycin (as the sulfate), 250 mg bis- (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), muth subcarbonate, and 500 mg acti- (e)(2)(ii)(B), and (e)(2)(iii) of this sec- vated attapulgite. tion; and for use of an 18.15-g package (b) Sponsor. See No. 054771 in as in paragraph (e)(3) of this section. § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of (c) Conditions of use in dogs—(1) this chapter. Amount. 5 mL of suspension or 1 tablet (d) Special considerations. See § 500.25 per 20 pounds body weight every 8 of this chapter. hours. Maximum dose: 5 mL of suspen- (e) Conditions of use. It is used as an sion or 3 tablets every 8 hours. Dogs anthelmintic as follows: under 10 pounds: 2.5 mL of suspension (1) Cattle—(i) Amount. 8 milligrams or 1⁄2 tablet every 8 hours. A rec- per kilogram (mg/kg) body weight as a ommended initial loading dose should drench. be twice the amount of a single dose. (ii) Indications for use—(A) Effective (2) Indications for use. For the treat- against the following nematode infec- ment of bacterial enteritis caused by tions: Stomach worms (Haemonchus, organisms susceptible to kanamycin Trichostrongylus, Ostertagia); intestinal and the symptomatic relief of the asso- worms (Trichostrongylus, Cooperia, ciated diarrhea. Nematodirus, Bunostomum, (3) Limitations. Federal law restricts Oesophagostomum); and lungworms this drug to use by or on the order of a (Dictyocaulus). licensed veterinarian. (B) Effective against the following adult nematode infections: Stomach [40 FR 13838, Mar. 27, 1975, as amended at 53 worms (Haemonchus placei, Ostertagia FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. ostertagi, Trichostrongylus axei); intes- 3, 2006; 78 FR 28822, May 20, 2014] tinal worms (T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus § 520.1242 Levamisole. spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum); and § 520.1242a Levamisole powder. lungworms (Dictyocaulus viviparus). (a) Specifications. Each package of (iii) Limitations. Do not slaughter for powder contains 9.075, 11.7, 18.15, 46.8, food within 48 hours of treatment. Not 362.7, or 544.5 grams (g) levamisole hy- for use in dairy animals of breeding drochloride. age. Conditions of constant helminth (b) Sponsors. See sponsors in exposure may require retreatment 2 to § 510.600(c) for use as follows: 4 weeks after the first treatment. Con- (1) No. 000061 for use of 46.8- and 544.5- sult your veterinarian before using in g packages as in paragraph (e)(1)(i), severely debilitated animals.

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(2) Sheep—(i) Amount. 8 mg/kg body (c) Required labeling. Consult your weight as a drench. veterinarian for assistance in the diag- (ii) Indications for use—(A) Effective nosis, treatment, and control of para- against the following nematode infec- sitism. tions: Stomach worms (Haemonchus, (d) Related tolerances. See § 556.350 of Trichostrongylus, Ostertagia); intestinal this chapter. worms (Trichostrongylus, Cooperia, (e) Conditions of use—(1) Cattle—(i) Nematodirus, Bunostomum, Amount. Administer orally 2.19-gram Oesophagostomum, Chabertia); and boluses as a single dose as follows: 250 lungworms (Dictyocaulus). to 450 pounds, 1⁄2 bolus; 450 to 750 (B) Effective against the following pounds, 1 bolus; and 750 to 1,050 pounds, adult nematode infections: Stomach 11⁄2 boluses. worms (Haemonchus contortus, (ii) Indications for use. Anthelmintic Trichostrongylus axei, Teladorsagia effective against the following nema- circumcincta); intestinal worms tode infections: Stomach worms (Trichostrongylus colubriformis, Cooperia (Haemonchus, Trichostrongylus, curticei, Nematodirus spathiger, Ostertagia), intestinal worms Bunostomum trigonocephalum, (Trichostrongylus, Cooperia, Oesophagostomum columbianum, Nematodirus, Bunostomum, Chabertia ovina), and lungworms Oesophagostomum), and lungworms (Dictyocaulus filaria). (Dictyocaulus). (iii) Limitations. Do not slaughter for (iii) Limitations. Conditions of con- food within 72 hours of treatment. Con- stant helminth exposure may require ditions of constant helminth exposure re-treatment within 2 to 4 weeks after may require retreatment 2 to 4 weeks the first treatment. Do not slaughter after the first treatment. Consult vet- for food within 48 hours of treatment. erinarian before using in severely de- Not for use in dairy animals of breed- bilitated animals. ing age. Consult veterinarian before (3) Swine—(i) Amount. 8 mg/kg body using in severely debilitated animals. weight in drinking water. (2) Sheep—(i) Amount. Administer (ii) Indications for use. Effective orally one 0.184-gram oblet for each 50 against the following nematode infec- pounds of body weight. tions: Large roundworms (Ascaris (ii) Indications for use. Anthelmintic suum), nodular worms effective against the following nema- (Oesophagostomum spp.), intestinal tode infections: Stomach worms thread worms (Strongyloides ransomi) (Haemonchus, Trichostrongylus, and lungworms (Metastrongylus spp. ). Ostertagia), intestinal worms (iii) Limitations. Do not administer (Trichostrongylus, Cooperia, within 72 hours of slaughter for food. Nematodirus, Bunostomum, Pigs maintained under conditions of Oesophagostomum, Chabertia), and constant exposure to worms may re- lungworms (Dictyocaulus). quire retreatment within 4 to 5 weeks (iii) Limitations. Conditions of con- after the first treatment. Consult your stant helminth exposure may require veterinarian before administering to re-treatment within 2 to 4 weeks after sick swine. the first treatment. Do not slaughter for food within 72 hours of treatment. [69 FR 9753, Mar. 2, 2004, as amended at 69 FR Consult a veterinarian before using in 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; severely debilitated animals. 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014] [78 FR 28822, May 20, 2014]

§ 520.1242b Levamisol boluses or § 520.1242c Levamisol and piperazine. oblets. (a) Specifications. (1) Each ounce of (a) Specifications. Each bolus contains solution contains 0.36 gram of 2.19 grams levamisol hydrochloride. levamisole hydrochloride and piper- Each oblet contains 0.184 grams azine dihydrochloride equivalent to 3.98 levamisol hydrochloride. grams of piperazine base. (b) Sponsors. See Nos. 000061 and (2) A soluble powder which when con- 054771 in § 510.600(c) of this chapter. stituted with water contains in each

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fluid ounce 0.45 gram of levamisole hy- packet of levamisole resinate con- drochloride and piperazine taining the equivalent of 10-percent dihydrochloride equivalent to 5.0 grams levamisole hydrochloride in 40 pounds of piperazine base. of feed and administer 1 pound of medi- (b) Sponsor. See No. 054771 in cated feed per 40 pounds of body weight § 510.600(c) of this chapter. as sole ration. For breeding swine, mix (c) Conditions of use in horses—(1) 1 packet of the 10-percent resinate in 16 Amount. Aqueous solution: administer pounds of feed and administer 1 pound by stomach tube or drench 1 fluid of medicated feed per 100 pounds of ounce per 100 pounds of body weight. body weight as sole ration. Administer Reconstituted soluble powder: admin- as single doses. Withhold regular feed ister by stomach tube 1 fluid ounce per overnight and administer medicated 125 pounds of body weight. If reinfec- feed the following morning. Do not tion occurs, re-treat animals at 6- to 8- withhold water during fasting. Do not week intervals. treat within 72 hours of slaughter. Sali- (2) Indications for use. An anthel- vation or muzzle foam may be ob- mintic effective against infections of served. The reaction will disappear a large strongyles (Strongylus vulgaris, S. short time after feeding. If pigs are in- edentatus), small strongyles fected with mature lungworms, (Cylicocercus spp., Cylicocyclus spp., coughing and vomiting may be ob- Cylicodontophorus spp., Cylicostephanus served. Consult your veterinarian for spp., Cylicotetrapedon spp.), ascarids assistance in the diagnosis, treatment, (Parascaris equorum), and pinworms and control of parasitism. (Oxyuris equi). (3) Limitations. Do not use in horses [43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1242e Levamisole hydrochloride on the order of a licensed veterinarian. effervescent tablets. [78 FR 28823, May 20, 2014] (a) Specifications. Each tablet con- tains 907 milligrams of levamisole hy- § 520.1242d Levamisole resinate. drochloride. (a) Specifications. The drug is (b) Sponsor. See No. 054771 in levamisole adsorbed on a resin, in a § 510.600(c) of this chapter. concentration equivalent to 10 percent (c) Related tolerances. See § 556.350 of levamisole hydrochloride. Each 2.05- this chapter. ounce (58.1 gram) packet contains (d) Conditions of use. It is used for levamisole equivalent to 5.806 grams of swine as follows: levamisole hydrochloride. (1) Amount. The equivalent of 8 milli- (b) Sponsor. See No. 043781 in grams of levamisole hydrochloride per § 510.600(c) of this chapter. kilogram of body weight, as a single (c) Related tolerances. See § 556.350 of dose. this chapter. (2) Indications for use. See (d) Conditions of use. In swine it is § 520.1242a(f)(3)(ii). used as follows: (3) Limitations. Withholding water (1) Amount. The equivalent of 8 milli- from pigs before treatment is not nec- grams per kilogram of body weight, as essary. Add one tablet for each 21⁄2 gal- a single dose, mixed in the animal’s ra- lons of water; mix thoroughly. Allow 1 tion. gallon of medicated water for each 100 (2) Indications for use. For the re- pounds body weight of pigs to be treat- moval of and control of the following ed. No other source of water should be nematode infections: large roundworms offered. After pigs have consumed (Ascaris suum), nodular worms medicated water, resume use of regular (Oesophagostomum spp.), lungworms water. Pigs maintained under condi- (Metastrongylus spp.), intestinal tions of constant worm exposure may threadworms (Strongyloides ransomi), require re-treatment within 4 to 5 and swine kidney worms (Stephanurus weeks. Consult your veterinarian be- dentatum). fore administering to sick swine. Con- (3) Limitations. For pigs from weaning sult your veterinarian for assistance in to market weight, mix one 58.1-gram the diagnosis, treatment, and control

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of parasitism. Do not administer with- and in the diagnosis, treatment, and in 72 hours of slaughter for food. control of parasitism. [45 FR 6087, Jan. 25, 1980, as amended at 67 [47 FR 22517, May 25, 1982; 47 FR 30242, July FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 13, 1982, as amended at 48 FR 11429, Mar. 18, 2014] 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] § 520.1242f Levamisol gel. (a) Specifications. Each gram of gel § 520.1242g Levamisole resinate and famphur paste. contains 115 milligrams (11.5 percent) levamisol hydrochloride. (a) Specifications. The drug is a paste (b) Sponsor. See No. 054771 in containing 11.6 percent levamisole res- § 510.600(c) of this chapter. inate (50 percent potency) and 23.6 per- (c) Related tolerances. See § 556.350 of cent famphur. this chapter. (b) Sponsor. See 000061 in § 510.600(c) of (d) Conditions of use—(1) Cattle—(i) this chapter. Amount. Eight milligrams of (c) Special considerations. Do not use levamisole hydrochloride per kilogram any cholinesterase-inhibiting drugs, of body weight, as a single oral dose. pesticides, insecticides, or chemicals (ii) Indications for use. Anthelmintic on cattle simultaneously or within a effective against the following nema- few days before or after treatment with tode infections: Stomach worms this product. (Haemonchus, Trichostrongylus, (d) Related tolerances. See §§ 556.273 Ostertagia), intestinal worms and 556.350 of this chapter. (Trichostrongylus, Cooperia, (e) Conditions of use in cattle—(1) Nematodirus, Bunostomum, Amount. 8 milligrams of levamisole hy- Oesophagostomum), and lungworms drochloride (equivalent) and 30 milli- (Dictyocaulus). grams of famphur activity per kilo- (iii) Limitations. Conditions of con- gram of body weight. stant helminth exposure may require (2) Indications for use. For treatment re-treatment within 2 to 4 weeks after of cattle infected with the following the first treatment; do not administer parasites: Stomach worms to cattle within 6 days of slaughter for (Haemonchus, Trichostrongylus, food; do not administer to dairy ani- Ostertagia), intestinal worms mals of breeding age; consult veteri- (Trichostrongylus, Cooperia, narian before using in severely debili- Nematodirus, Bunostomum, tated animals. Oesophagostomum), lungworms (2) Breeding swine—(i) Amount. Eight (Dictyocaulus), cattle grubs milligrams per kilogram of body (Hypoderma), biting lice (Bovicola), and weight (3.6 milligrams per pound) as a sucking lice (Linognathus, Solenoptes). single oral dose. (3) Limitations. Drug is not effective (ii) Conditions of use. For treating against lice eggs. Conditions of con- breeding swine infected with the fol- stant helminth and ectoparasitic expo- lowing nematodes: Large roundworms sure may require retreatment within 2 (Ascaris suum), nodular worms to 4 weeks after first treatment. Do not (Oesophagostomum spp.), lungworms administer to cattle within 19 days of (Metastrongylus spp.), intestinal slaughter. Do not administer to dairy threadworms (Strongyloides ransomi), animals of breeding age. Do not use in and kidney worms (Stephanurus calves less than 3 months old, or in de- dentatus). bilitated animals. Do not treat Brah- (iii) Limitations. May require retreat- man bulls. Consult your veterinarian ment in 4 to 5 weeks. Do not use within for assistance in the diagnosis, treat- 11 days of slaughter for food. Consult ment, and control of parasitism. your veterinarian for assistance before [53 FR 23757, June 24, 1988, as amended at 54 using in severely debilitated animals FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997; 78 FR 28823, May 20, 2014]

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§ 520.1248 Levothyroxine. (1) Nos. 016592 and 054771 for use as in paragraph (d) of this section. (a) Specifications. Each tablet con- (2) Nos. 054925, 061623, and 076475 for tains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or use as in paragraphs (d)(1) and (d)(2) of 1.0 milligrams (mg) levothyroxine so- this section. dium. (c) Tolerances. See § 556.360 of this (b) Sponsor. See No. 061690 in chapter. § 510.600(c) of this chapter. (d) Conditions of use—(1) Swine—(i) (c) Conditions of use—(1) Amount. Ad- Amount. 250 milligrams per gallon of minister by mouth 0.1 mg/10 pounds of drinking water to provide 3.8 milli- body weight (0.022 mg/kilogram) as a grams per pound of body weight per single dose every 24 hours or as a di- day. vided dose every 12 hours. (ii) Indications for use. For the treat- (2) Indications for use. For replace- ment of swine dysentery (bloody ment therapy for diminished thyroid scours). function in dogs. (iii) Limitations. Discard medicated (3) Limitations. Federal law restricts drinking water if not used within 2 this drug to use by or on the order of a days. Prepare fresh stock solution licensed veterinarian. daily. Do not use for more than 10 days. [81 FR 22523, Apr. 18, 2016] If clinical signs of disease have not im- proved within 6 days, discontinue § 520.1263 Lincomycin. treatment and reevaluate diagnosis. The safety of lincomycin has not been § 520.1263a Lincomycin tablets and demonstrated in pregnant swine or syrup. swine intended for breeding. For No. (a) Specifications. (1) Each ounce of 054925: Do not slaughter swine for 6 syrup contains lincomycin hydro- days following last treatment. Federal chloride equivalent to either 25 or 50 law restricts this drug to use by or on milligrams (mg) lincomycin. the order of a licensed veterinarian. (2) Each tablet contains lincomycin (2) Chickens—(i) Amount. 64 milli- hydrochloride equivalent to either 25 grams per gallon of drinking water. or 50 mg lincomycin. (ii) Indications for use. For the control (b) Sponsor. See No. 054771 in of necrotic enteritis caused by Clos- § 510.600(c) of this chapter. tridium perfringens susceptible to linco- (c) Conditions of use in dogs and cats— mycin in broiler chickens. (1) Amount. Administer orally 10 mg per (iii) Limitations. Discard medicated pound of body weight every 12 hours, or drinking water if not used within 2 7 mg per pound of body weight every 8 days. Prepare fresh stock solution hours, for up to 12 days. daily. Administer for 7 consecutive (2) Indications for use. For infections days. Do not allow rabbits, hamsters, caused by gram-positive organisms guinea pigs, horses, or ruminants ac- which are sensitive to its action, par- cess to water containing lincomycin. ticularly streptococci and Not for use in layer and breeder chick- staphylococci. ens. Federal law restricts this drug to use by or on the order of a licensed vet- (3) Limitations. Federal law restricts erinarian. this drug to use by or on the order of a (3) —(i) Mix 100 licensed veterinarian. Honey bees Amount. milligrams lincomycin with 20 grams [78 FR 28823, May 20, 2014] confectioners’/powdered sugar and dust over the top bars of the brood chamber § 520.1263b [Reserved] once weekly for 3 weeks. (ii) Indications for use. For the control § 520.1263c Lincomycin powder. of American foulbrood (Paenibacillus (a) Specifications. Each gram of solu- larvae). ble powder contains lincomycin hydro- (iii) Limitations. The drug should be chloride equivalent to 0.4 grams of lin- fed early in the spring or late in the comycin. fall and consumed by the bees before (b) Sponsors. See sponsor numbers in the main honey flow begins to avoid § 510.600(c) of this chapter as follows: contamination of production honey.

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Complete treatments at least 4 weeks (3) Limitations. Federal law restricts before main honey flow. Federal law re- this drug to use by or on the order of a stricts this drug to use by or on the licensed veterinarian. order of a licensed veterinarian. [69 FR 13220, Mar. 22, 2004, as amended at 70 [48 FR 3966, Jan. 28, 1983, as amended at 55 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, May 20, 2014; 81 FR 94989, Dec. 27, 2016] 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR § 520.1284 Liothyronine. 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, (a) Specifications. Each tablet con- 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, tains 60 or 120 micrograms (μg) Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR liothyronine as the sodium salt. 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; (b) Sponsor. See No. 054771 in 78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, § 510.600(c) of this chapter. 2016; 81 FR 94989, Dec. 27, 2016] (c) Conditions of use in dogs—(1) Amount. Administer orally to dogs at § 520.1265 Lincomycin and levels up to 12.8 μg per kilogram (/kg) spectinomycin powder. of body weight per day. Dosage should (a) Specifications. The following salts be adjusted according to the severity of of lincomycin and spectinomycin are the condition and the response of the present in a soluble powder in the ratio patient. Dosage at the total replace- of 1 to 2 on the basis of equivalency of ment level (12.8 μg/kg of body weight) lincomycin base to equivalency of should be considered for initiating spectinomycin base: therapy and then titrated downward (1) Lincomycin hydrochloride for optimum maintenance effect. Twice monohydrate and spectinomycin sul- daily administration is recommended. fate tetrahydrate. (2) Indications for use. For treatment (2) Lincomycin hydrochloride of hypothyroidism in dogs. monohydrate and spectinomycin (3) Limitations. Federal law restricts dihydrochloride pentahydrate. this drug to use by or on the order of a licensed veterinarian. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in [78 FR 28823, May 20, 2014] paragraph (d) of this section. (1) No. 054771 for use of product de- § 520.1288 Lufenuron tablets. scribed in paragraph (a)(1) of this sec- (a) Specifications—(1) Tablets con- tion. taining 45, 90, 204.9, or 409.8 milligrams (2) Nos. 057561, 061623, and 066104 for (mg) lufenuron for use as in paragraphs use of product described in paragraph (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (a)(2) of this section. (c)(2)(ii)(A), and (c)(2)(iii) of this sec- tion. (c) Tolerances. See §§ 556.360 and (2) Flavored tablets containing 45, 90, 556.600 of this chapter. 204.9, or 409.8 milligrams (mg) (d) Conditions of use in chickens—(1) lufenuron for use as in paragraphs Amount. 2 grams of antibiotic activity (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and per gallon of drinking water; admin- (c)(1)(iii) of this section. ister as the sole source of water for the (3) Flavored tablets containing 90 or first 5 to 7 days of life. 204.9 mg lufenuron for use as in para- (2) Indications for use. As an aid in the graphs (c)(2)(i), (c)(2)(ii)(A) or control of airsacculitis caused by ei- (c)(2)(ii)(B), and (c)(2)(iii) of this sec- ther Mycoplasma synoviae or M. tion. gallisepticum susceptible to lincomycin- (4) Flavored tablets containing 135 or spectinomycin and complicated chron- 270 mg lufenuron for use as in para- ic respiratory disease (air sac infec- graphs (c)(2)(i), (c)(2)(ii)(A), and tion) caused by Escherichia coli and M. (c)(2)(iii) of this section. gallisepticum susceptible to lincomycin- (b) Sponsor. See No. 058198 in spectinomycin. § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Minimum of 10 mg lufenuron

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per kilogram (4.5 mg per pound (lb)) of essary depending on the severity of the body weight, once a month. infestation. (ii) Indications for use—(A) For the [60 FR 20402, Apr. 26, 1995, as amended at 62 prevention and control of flea popu- FR 8371, Feb. 25, 1997] lations. (B) The concurrent use of flavored § 520.1310 Marbofloxacin. lufenuron tablets described in para- (a) Specifications. Each tablet con- graph (a)(2) of this section as in para- tains 25, 50, 100, or 200 milligrams (mg) graph (c)(1)(ii)(A) of this section with marbofloxacin. nitenpyram tablets as in § 520.1510(d)(1) of this chapter is indicated to kill (b) Sponsor. See No. 054771 in adult fleas and prevent flea eggs from § 510.600(c) of this chapter. hatching. (c) [Reserved] (iii) Limitations. For use in dogs and (d) Conditions of use—(1) Amount. 1.25 puppies 4 weeks of age and older. mg per pound (/lb) of body weight once (2) Cats—(i) Amount. Minimum of 30 daily, but may be increased to 2.5 mg/ mg lufenuron per kilogram (13.6 mg/lb) lb of body weight once daily. of body weight, once a month. (2) Indications for use. For the treat- (ii) Indications for use—(A) For the ment of infections in dogs and cats as- control of flea populations. sociated with bacteria susceptible to (B) The concurrent use of flavored marbofloxacin. lufenuron tablets described in para- (3) Limitations. Federal law restricts graph (a)(3) of this section as in para- this drug to use by or on the order of a graph (c)(2)(ii)(A) of this section with licensed veterinarian. Federal law pro- nitenpyram tablets as in § 520.1510(d)(2) hibits the extralabel use of this drug in of this chapter is indicated to kill food-producing animals. adult fleas and prevent flea eggs from [64 FR 39919, July 23, 1999, as amended at 66 hatching. FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, (iii) Limitations. For use in cats and 2014] kittens 4 weeks of age and older. § 520.1315 Maropitant. [68 FR 51905, Aug. 29, 2003] (a) Specifications. Each tablet con- § 520.1289 Lufenuron suspension. tains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate. (a) Specifications. Each individual (b) See No. 054771 in dose pack contains either 135 or 270 Sponsor. § 510.600(c) of this chapter. milligrams of lufenuron. (b) Sponsor. See No. 058198 in (c) Conditions of use in dogs—(1) Indi- § 510.600(c) of this chapter. cations for use and amount. (i) For pre- vention of acute vomiting in dogs 2 to (c) Conditions of use in cats—(1) 7 months of age, administer a min- Amount. Minimum of 13.6 milligrams imum dose of 2.0 mg per kilogram (/kg) per pound of body weight (30 milli- body weight once daily for up to 5 con- grams per kilogram). Recommended secutive days. dose of 135 milligrams for up to 10 pounds of body weight or 270 milli- (ii) For prevention of acute vomiting grams for 11 to 20 pounds. Cats over 20 in dogs 7 months of age and older, ad- pounds are provided the appropriate minister a minimum dose of 2.0 mg/kg combination of packs. body weight once daily until resolution of acute vomiting. (2) Indications for use. For control of flea populations. (iii) For prevention of vomiting due (3) Limitations. For oral use in cats 6 to motion sickness in dogs 4 months of weeks of age or older, once a month, age and older, administer a minimum mixed with food. Administer in con- of 8.0 mg/kg body weight once daily for junction with a full meal to ensure ade- up to 2 consecutive days. quate absorption. Treat all cats in the (2) Limitations. Federal law restricts household to ensure maximum bene- this drug to use by or on the order of a fits. Because the drug has no affect on licensed veterinarian. adult fleas, the concurrent use of insec- [72 FR 9243, Mar. 1, 2007, as amended at 78 FR ticides that kill adults may be nec- 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015]

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§ 520.1320 Mebendazole. and 40 milligrams of trichlorofon per kilogram of body weight. (a) Specifications. (1) Each gram of powder contains either 40 or 166.7 milli- (2) Indications for use. It is used in grams of mebendazole. horses for the treatment of infections (2) Each gram of paste contains 200 of bots (Gastrophilus intestinalis and G. milligrams of mebendazole. nasalis), large roundworms (Parascaris equorum), large strongyles (Strongylus (3) Each milliliter of suspension con- edentatus, S. equinus, S. vulgaris), small tains 33.3 milligrams of mebendazole. strongyles, and pinworms (Oxyuris (b) Sponsor. See No. 000061 in equi.) § 510.600(c) of this chapter. (3) Limitations. Do not use in horses (c) Conditions of use—(1) Horses—(i) intended for human consumption. Fed- Amount. 1 gram of mebendazole per 250 eral law restricts this drug to use by or pounds of body weight per dose, as an on the order of a licensed veterinarian. oral powder, paste or suspension. (ii) Indications for use. For treatment [45 FR 10759, Feb. 19, 1980, as amended at 46 of infections caused by large FR 52330, Oct. 27, 1981. Redesignated at 51 FR roundworms (Parascaris equorum); large 13212, Apr. 18, 1986, as amended at 62 FR strongyles (Strongylus edentatus, S. 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] equinus, S. vulgaris); small strongyles; and mature and immature (4th larval § 520.1326b Mebendazole and trichlorfon paste. stage) pinworms (Oxyuris equi). (iii) Limitations. The drug is compat- (a) Specifications. Each gram of paste ible with carbon disulfide. Do not use contains 100 milligrams of mebendazole in horses intended for human consump- and 454 milligrams of trichlorfon. tion. Federal law restricts this drug to (b) Sponsor. See No. 000061 in use by or on the order of a licensed vet- § 510.600(c) of this chapter. erinarian. (c) Conditions of use in horses—(1) (2) Dogs—(i) Amount. Administer 100 Amount. 8.8 milligrams of mebendazole milligrams of mebendazole per 10 and 40 milligrams of trichlorfon per pounds of body weight, once daily for 3 kilogram of body weight. days, as an oral powder by mixing with (2) Indications for use. It is used in a small quantity of food, preferably be- horses for treatment of infections of fore the regular meal. bots (Gastrophilus intestinalis and G. na- (ii) Indications for use. The drug is salis), large roundworms (Parascaris used for treatment of infections of equorum), large strongyles (Strongylus roundworms (Toxocara canis), edentatus, S. equinus, S. vulgaris), small hookworms (Ancylostoma caninum, strongyles, and pinworms (Oxyuris Uncinaria stenocephala), whipworms equi). (Trichuris vulpis), and tapeworms (3) Limitations. Do not administer (Taenia pisiformis). more than once every 30 days. Do not (iii) Limitations. Federal law restricts treat sick or debilitated animals, foals this drug to use by or on the order of a under 4 months of age, or mares in the licensed veterinarian. last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not ad- [78 FR 28823, May 20, 2014] minister simultaneously or within a § 520.1326 Mebendazole and few days before or after treatment trichlorfon oral dosage forms. with, or exposure to, cholinesterase-in- hibiting drugs, pesticides, or chemi- § 520.1326a Mebendazole and cals. Do not administer intravenous trichlorfon powder. anesthetics, especially muscle relax- (a) Specifications. Each gram of pow- ants, concurrently. Not for use in der contains 83.3 milligrams of horses intended for food. Consult your mebendazole and 375.0 milligrams of veterinarian for assistance in the diag- trichlorofon. nosis, treatment, and control of para- (b) Sponsor. See No. 000061 in sitism. § 510.600(c) of this chapter. [51 FR 13212, Apr. 18, 1986, as amended at 62 (c) Conditions of use in horses—(1) FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, Amount. 8.8 milligrams of mebendazole 2014]

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§ 520.1330 Meclofenamic acid granules. per pound of body weight per day for 32 days. (a) Specifications. Each gram of gran- (iii) For alleviation of false preg- ules contains 5 milligrams (5 percent) nancy: 1 milligram per pound of body meclofenamic acid. weight per day for 8 days. (b) Sponsor. See No. 054771 in (2) Indications for use. For the post- § 510.600(c) of this chapter. ponement of estrus and the alleviation (c) Conditions of use in horses—(1) of false pregnancy in female dogs. Amount. Administer 1 milligram per (3) Limitations. Federal law restricts pound of body weight (1 gram per 1000 this drug to use by or on the order of a pounds) once daily for 5 to 7 days by licensed veterinarian. addition to the daily grain ration. (2) Indications for use. For the treat- [40 FR 13838, Mar. 27, 1975, as amended at 52 ment of acute or chronic inflammatory FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, 2014] diseases involving the musculoskeletal system. § 520.1367 Meloxicam. (3) Limitations. Do not use in horses (a) Specifications—(1) Each milliliter intended for human consumption. Fed- of suspension contains 0.5 milligrams eral law restricts this drug to use by or (mg) meloxicam. on the order of a licensed veterinarian. (2) Each milliliter of suspension con- [78 FR 28824, May 20, 2014] tains 1.5 mg meloxicam. (b) Sponsors. See sponsors in § 520.1331 Meclofenamic acid tablets. § 510.600(c) of this chapter for uses as in (a) Specifications. Each tablet con- paragraph (c) of this section: tains either 10 or 20 milligrams of (1) No. 000010 for use of the products meclofenamic acid. described in paragraph (a) of this sec- (b) Sponsor. See No. 054771 in tion; and § 510.600(c) of this chapter. (2) Nos. 013744 and 055529 for use of (c) Conditions of use in dogs—(1) the product described in paragraph Amount. 1.1 milligrams per kilogram (a)(2) of this section. (0.5 milligram per pound) daily for 5 to (c) Conditions of use in dogs—(1) 7 days. Amount. Administer orally as a single dose at 0.09 mg per pound (mg/lb) body (2) Indications for use. For the relief of weight (0.2 mg per kilogram (mg/kg)) signs and symptoms of chronic inflam- on the first day of treatment. For all matory disease involving the musculo- treatment after day 1, administer 0.045 skeletal system. mg/lb (0.1 mg/kg) body weight once (3) Limitations. Federal law restricts daily. this drug to use by or on the order of a (2) Indications for use. For the control licensed veterinarian. of pain and inflammation associated [50 FR 43385, Oct. 25, 1985, as amended at 53 with osteoarthritis. FR 23390, June 22, 1988; 78 FR 28824, May 20, (3) Limitations. Federal law restricts 2014] this drug to use by or on the order of a licensed veterinarian. § 520.1341 Megestrol. [68 FR 42968, July 21, 2003, as amended at 69 (a) Specifications. Each tablet con- FR 69523, Nov. 30, 2004. Redesignated and tains 5 or 20 milligrams of megestrol amended at 78 FR 57058, Sept. 17, 2013; 80 FR acetate. 53459, Sept. 4, 2015] (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. § 520.1372 Methimazole. (c) Conditions of use in dogs—(1) (a) Specifications. Each tablet con- Amount. Administer orally, intact, or tains 2.5 or 5 milligrams (mg) crushed and mixed with food as follows: methimazole. (i) For the postponement of estrus by (b) Sponsor. See No. 043264 in § 510.600 proestrus treatment: 1 milligram per of this chapter. pound of body weight per day for 8 (c) Conditions of use in cats—(1) days. Amount. The starting dose is 2.5 mg (ii) For the postponement of estrus every 12 hours. Following 3 weeks of by anestrus treatment: 0.25 milligram treatment, the dose should be titrated

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to effect based on individual serum § 520.1409 Methylprednisolone and as- total T4 levels and clinical response. pirin. (2) Indications for use. For the treat- (a) Specifications. Each tablet con- ment of hyperthyroidism. tains 0.5 milligram of (3) Limitations. Federal law restricts methylprednisolone and 300 milligrams this drug to use by or on the order of a of aspirin. licensed veterinarian. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. [74 FR 27707, June 11, 2009] (c) Conditions of use in dogs—(1) Amount. Under 15 pounds, 1⁄4 to 1 tablet § 520.1380 Methocarbamol. daily; 15 to 60 pounds, 1 to 2 tablets (a) Specifications. Each tablet con- daily; 60 pounds and over, 2 tablets tains 500 milligrams (mg) of daily. Administer total daily dose in methocarbamol. divided doses 6 to 10 hours apart, with (b) Sponsor. See No. 054771 in a light feeding. When response is at- § 510.600(c) of this chapter. tained, dosage should be gradually re- (c) Conditions of use in dogs and cats— duced until maintenance level is (1) Amount. Administer 60 mg per pound achieved. of body weight in two or three equally (2) Indications for use. As an anti-in- divided doses, followed each following flammatory and analgesic agent. day by 30 to 60 mg per pound of body (3) Limitations. Federal law restricts weight, usually not to exceed 14 to 21 this drug to use by or on the order of a licensed veterinarian. days. (2) Indications for use. As an adjunct [48 FR 21566, May 13, 1983, as amended at 78 to therapy for acute inflammatory and FR 28824, May 20, 2014] traumatic conditions of the skeletal § 520.1422 Metoserpate hydrochloride. muscles in order to reduce muscular spasms. (a) Chemical name. Methyl-o-methyl- (3) Limitations. Federal law restricts 18-epireserpate hydrochloride. this drug to use by or on the order of a (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.410 of [78 FR 28824, May 20, 2014] this chapter. (d) Conditions of use. It is used in § 520.1408 Methylprednisolone. drinking water for replacement chick- (a) Specifications. Each tablet con- ens as follows: tains 1, 2, or 4 milligrams (mg) of (1) Amount. 568.5 milligrams per gal- methylprednisolone. lon (0.015 percent). (i) Indications for use. As a tranquil- (b) Sponsors. See sponsors in izer for flock treatment of chickens § 510.600(c) of this chapter. prior to handling. (1) No. 054628 for use of 1- and 2-mg (ii) Limitations. To be used one time tablets. as a treatment for replacement chick- (2) No. 054771 for use of 1- and 4-mg ens up to 16 weeks of age; usual drink- tablets. ing water should be withheld prior to (c) Conditions of use in dogs and cats— treatment to provide adequate con- (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 sumption of medicated drinking water; to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 not for use in laying chickens; chick- mg. Administer total daily dose orally ens slaughtered within 72 hours fol- in equally divided doses 6 to 10 hours lowing treatment must not be used for apart until response is noted or 7 days food. have elapsed. (2) Amount. 2 to 4 milligrams per 2.2 (2) Indications for use. As an anti-in- pounds of body weight. flammatory agent. (i) Indications for use. As an aid in (3) Limitations. Federal law restricts control of hysteria. this drug to use by or on the order of a (ii) Limitations. To be used as a treat- ment for replacement chickens up to 16 licensed veterinarian. weeks of age; usual drinking water [78 FR 28824, May 20, 2014] should be withheld prior to treatment

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to provide adequate consumption of body weight (0.1 milligram per kilo- medicated drinking water; the drug gram). should be administered at a dosage (ii) Indications for use. For prevention level of 4 milligrams per 2.2 pounds of of heartworm disease caused by body weight followed by 2 treatments Dirofilaria immitis, control of hookworm at 4-day intervals of 2 milligrams per infections caused by Ancylostoma 2.2 pounds of body weight; not for use caninum, and removal and control of in laying chickens; chickens slaugh- adult roundworm infections caused by tered within 72 hours following treat- Toxocara canis and Toxascaris leonina ment must not be used for food. and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 [40 FR 13838, Mar. 27, 1975, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, weeks of age or greater and 2 pounds of 2014] body weight or greater. (iii) Limitations. Do not use in puppies § 520.1430 Mibolerone. less than 4 weeks of age and less than (a) Specifications. Each milliliter con- 2 pounds of body weight. Administer tains 100 micrograms of mibolerone. once a month. First dose given within (b) Sponsor. See No. 054771 in 1 month after first exposure to mosqui- § 510.600(c) of this chapter. toes and continue regular use until at (c) Conditions of use in dogs—(1) least 1 month after end of mosquito Amount. 30 micrograms for animals season. Federal law restricts this drug weighing 1 to 25 pounds; 60 micrograms to use by or on the order of a licensed for animals weighing 26 to 50 pounds; veterinarian. 120 micrograms for animals weighing 51 (2) Cats and kittens—(i) Amount. 0.91 to 100 pounds; 180 micrograms for ani- milligram per pound of body weight (2.0 mals weighing over 100 pounds, German milligrams per kilogram). Shepherds, or German Shepherd mix. (ii) Indications for use. For prevention Administer daily, orally or in a small of heartworm disease caused by amount of food, at least 30 days before Dirofilaria immitis and the removal of expected initiation of heat, and con- adult Toxocara cati (roundworm) and tinue daily as long as desired, but not Ancylostoma tubaeforme (hookworm) in- for more than 24 months. fections in cats 6 weeks of age or great- (2) Indications for use. For the preven- er and 1.5 pounds body weight or great- tion of estrus (heat) in adult female er. dogs not intended primarily for breed- (iii) Limitations. Do not use in kittens ing purposes. less than 6 weeks of age or 1.5 pounds (3) Limitations. Federal law restricts body weight. Administer once a month. this drug to use by or on the order of a Federal law restricts this drug to use licensed veterinarian. by or on the order of a licensed veteri- narian. [43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014] [55 FR 25301, June 21, 1990, as amended at 55 FR 49888, Dec. 3, 1990; 58 FR 5608, Jan. 22, § 520.1441 Milbemycin oxime. 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, Aug. 26, 1996; 63 FR 29352, May 29, 1998; 63 FR (a) Specifications—(1) Dogs. Each tab- 41189, Aug. 3, 1998. Redesignated at 77 FR let contains 2.3, 5.75, 11.5, or 23.0 milli- 47512, Aug. 9, 2012] grams of milbemycin oxime. (2) Cats. Each tablet contains 5.75, § 520.1443 Milbemycin oxime and 11.5, or 23.0 milligrams of milbemycin lufenuron. oxime. (a) Specifications—(1) Tablets con- (b) Sponsor. See 058198 in § 510.600(c) of taining: 2.3 milligrams (mg) this chapter. milbemycin oxime and 46 mg (c) [Reserved] lufenuron, 5.75 mg milbemycin oxime (d) Conditions of use—(1) Dogs and and 115 mg lufenuron, 11.5 mg puppies—(i) Amount. For hookworm, milbemycin oxime and 230 mg roundworm, and whipworm, use 0.23 lufenuron, or 23 mg milbemycin oxime milligram per pound of body weight (0.5 and 460 mg lufenuron. milligram per kilogram). For heart- (2) Flavored tablets containing: 2.3 worm, use 0.05 milligram per pound of mg milbemycin oxime and 46 mg

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lufenuron, 5.75 mg milbemycin oxime oxime and 2.28 mg/lb of body weight (5 and 115 mg lufenuron, 11.5 mg mg/kg) praziquantel. milbemycin oxime and 230 mg (ii) Indications for use. For the pre- lufenuron, or 23 mg milbemycin oxime vention of heartworm disease caused and 460 mg lufenuron. by Dirofilaria immitis and for the treat- (b) Sponsor. See No. 051311 in ment and control of adult roundworm § 510.600(c) of this chapter. (Toxocara canis, Toxascaris leonina), (c) [Reserved] adult hookworm (Ancylostoma (d) Conditions of use—(1) Dogs—(i) caninum), adult whipworm (Trichuris Amount. 0.5 mg milbemycin oxime and vulpis), and adult tapeworm (Taenia 10 mg lufenuron per kilogram of body pisiformis, Echinococcus multilocularis, weight, once a month. and E. granulosus) infections in dogs (ii) Indications for use—(A) For use in and puppies 2 pounds of body weight or dogs and puppies for the prevention of greater and 6 weeks of age and older. heartworm disease caused by Dirofilaria (iii) Limitations. Federal law restricts immitis, for prevention and control of this drug to use by or on the order of a flea populations, for control of adult licensed veterinarian. Ancylostoma caninum (hookworm), and (2) [Reserved] for removal and control of adult [77 FR 47512, Aug. 9, 2012] Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis § 520.1447 Milbemycin oxime, (whipworm) infections. lufenuron, and praziquantel tablets. (B) The concurrent use of flavored (a) Specifications. Each tablet con- milbemycin oxime and lufenuron tab- tains: lets described in paragraph (a)(2) of (1) 2.3 milligrams (mg) milbemycin this section as in paragraph (d)(1)(ii)(A) oxime, 46 mg lufenuron, and 22.8 mg of this section with nitenpyram tablets praziquantel; as in § 520.1510(d)(1) of this chapter is (2) 5.75 mg milbemycin oxime, 115 mg indicated to kill adult fleas and pre- lufenuron, and 57 mg praziquantel; vent flea eggs from hatching. (3) 11.5 mg milbemycin oxime, 230 mg (iii) Limitations. Federal law restricts lufenuron, and 114 mg praziquantel; or this drug to use by or on the order of a (4) 23 mg milbemycin oxime, 460 mg licensed veterinarian. lufenuron, and 228 mg praziquantel. (2) [Reserved] (b) Sponsor. See No. 051311 in [62 FR 28629, May 27, 1997, as amended at 63 § 510.600(c) of this chapter. FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, (c) [Reserved] 2003. Redesignated at 77 FR 47512, Aug. 9, (d) Conditions of use—(1) Dogs—(i) 2012, as amended at 80 FR 18776, Apr. 8, 2015] Amount. 0.5 mg milbemycin oxime, 10 mg lufenuron, and 5 mg of praziquantel § 520.1445 Milbemycin oxime and praziquantel. per kilogram of body weight, once a month. (a) Specifications. Each chewable tab- (ii) Indications for use. For the pre- let contains: vention of heartworm disease caused (1) 2.3 milligrams (mg) milbemycin by Dirofilaria immitis; for the prevention oxime and 22.8 mg praziquantel; and control of flea populations (2) 5.75 mg milbemycin oxime and 57 (Ctenocephalides felis); and for the treat- mg praziquantel; ment and control of adult roundworm (3) 11.5 mg milbemycin oxime and 114 (Toxocara canis, Toxascaris leonina), mg praziquantel; or adult hookworm (Ancylostoma (4) 23 mg milbemycin oxime and 228 caninum), adult whipworm (Trichuris mg praziquantel. vulpis), and adult tapeworm (Taenia (b) Sponsor. See No. 058198 in pisiformis, Echinococcus multilocularis, § 510.600(c) of this chapter. and E. granulosus) infections in dogs (c) Conditions of use—(1) Dogs—(i) and puppies 2 pounds of body weight or Amount. Administer orally, once a greater and 6 weeks of age and older. month, a minimum dosage of 0.23 mg (iii) Limitations. Federal law restricts per pound (mg/lb) of body weight (0.5 this drug to use by or on the order of a mg per kilogram (mg/kg)) milbemycin licensed veterinarian.

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(2) [Reserved] (d) Conditions of use—(1) Amount. Grazing cattle: Administer 1 cartridge [77 FR 4225, Jan. 27, 2012, as amended at 80 FR 18776, Apr. 8, 2015] to each animal at the start of the graz- ing season. § 520.1450 Morantel tartrate oral dos- (2) Indications for use. For control of age forms. the adult stage of the following gastro- intestinal nematode infections in § 520.1450a Morantel tartrate bolus. weaned calves and yearling cattle (a) Specifications. Each bolus contains weighing a minimum of 200 pounds: 2.2 grams morantel tartrate equivalent Ostertagia spp., Trichostrongylus axei, to 1.3 grams of morantel base. Cooperia spp., and Oesophagostomum (b) Sponsor. See No. 054771 in radiatum. § 510.600(c) of this chapter. (3) Limitations. Administer orally (c) Related tolerances. See § 556.425 of with the dosing gun to all cattle that this chapter. will be grazing the same pasture. Effec- (d) Conditions of use—(1) Amount. One tiveness of the drug product is depend- bolus per 500 pounds of body weight (4.4 ent upon continuous control of the gas- milligrams per pound of body weight) trointestinal parasites for approxi- as a single oral dose. Boluses may be mately 90 days following administra- divided in half for more accurate dos- tion. Therefore, treated cattle should ing as follows: up to 325 pounds, 1⁄2 not be moved to pastures grazed in the bolus; 326 to 600 pounds, 1 bolus; 601 to same grazing season/calendar year by 900 pounds, 11⁄2 boluses; and 901 to 1,200 untreated cattle. Do not administer to pounds, 2 boluses. cattle within 106 days of slaughter. (2) Indications for use. For removal Consult your veterinarian before ad- and control of mature gastrointestinal ministering to severely debilitated ani- nematode infections of cattle including mals and for assistance in the diag- stomach worms (Haemonchus spp., nosis, treatment, and control of para- Ostertagia spp., Trichostrongylus spp.), sitism. worms of the small intestine (Cooperia [49 FR 47831, Dec. 7, 1984, as amended at 51 spp., Trichostrongylus spp., Nematodirus FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, spp.), and worms of the large intestine 1986; 78 FR 28825, May 20, 2014] (Oesophagostomum radiatum). (3) Limitations. Conditions of constant § 520.1450c Morantel tartrate sus- worm exposure may require retreat- tained-release trilaminate cylinder/ ment in 2 to 4 weeks. Consult your vet- sheet. erinarian before administering to se- (a) Specifications. The drug product verely debilitated animals and for as- consists of a trilaminated, perforated, sistance in the diagnosis, treatment, plastic sheet formed into a cylinder and control of parasitism. Do not treat having plastic plugs in its ends. The within 14 days of slaughter. core lamina contains 19.8 grams of [46 FR 50949, Oct. 16, 1981. Redesignated at 49 morantel tartrate equivalent to 11.8 FR 47831, Dec. 7, 1984, and amended at 51 FR grams of morantel base. 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] (b) Sponsor. See 054771 in § 510.600(c) of this chapter. § 520.1450b Morantel tartrate car- (c) Related tolerances. See § 556.425 of tridge. this chapter. (a) Specifications. The drug product (d) Conditions of use—(1) Amount. consists of a stainless-steel cylinder Grazing cattle: Administer 1 cartridge having both ends closed with poly- to each animal at the start of the graz- ethylene diffusing discs and containing ing season. a morantel tartrate paste. The paste (2) Indications for use. For control of contains 22.7 grams of morantel tar- the adult stage of the following gastro- trate equivalent to 13.5 grams of intestinal nematode infections in morantel base. weaned calves and yearling cattle (b) Sponsor. See No. 054771 in weighing a minimum of 200 pounds: § 510.600(c) of this chapter. Ostertagia spp., Trichostrongylus axei, (c) Related tolerances. See § 556.425 of Cooperia spp., and Oesophagostomum this chapter. radiatum.

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(3) Limitations. Administer orally (adults); small strongyles (adults): with the dosing gun to all cattle that Cyathostomum spp., including C. will be grazing the same pasture. Effec- catinatum and C. pateratum; tiveness of the drug product is depend- Cylicocyclus. spp., including C. insigne, ent upon continuous control of the gas- C. leptostomum, C. nassatus, and C. trointestinal parasites for approxi- radiatus; Cyliocostephanus spp., includ- mately 90 days following administra- ing C. calicatus, C. goldi, C. tion. Therefore, treated cattle should longibursatus, and C. minutus; not be moved to pastures grazed in the Coronocyclus spp., including C. same grazing season/calendar year by coronatus, C. labiatus, and C. labratus; untreated cattle. Do not administer to Gyalocephalus capitatus; and cattle within 102 days of slaughter. Petrovinema poculatus; small Consult your veterinarian before ad- strongyles: undifferentiated lumenal ministering to severely debilitated ani- larvae; encysted cyathostomes (late L3 mals and for assistance in the diag- and L4 mucosal cyathostome larvae); nosis, treatment, and control of para- ascarids: Parascaris equorum (adults and sitism. L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014] hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: § 520.1451 Moxidectin tablets. Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (a) Specifications. Each tablet con- (2nd and 3rd instars) and G. nasalis (3rd tains 30, 68, or 136 micrograms of instars). One dose also suppresses moxidectin. strongyle egg production for 84 days. (b) Sponsor. See No. 054771 in (3) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. (c) Conditions of use—(1) Amount. 3 micrograms per kilogram (1.36 [62 FR 42902, Aug. 11, 1997, as amended at 64 micrograms per pound) of body weight. FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, (2) Indications for use. To prevent in- 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, fection by the canine heartworm Dec. 19, 2005; 78 FR 28825, May 20, 2014] Dirofilaria immitis and the subsequent § 520.1453 Moxidectin and development of canine heartworm dis- praziquantel gel. ease. (a) Specifications. Each milliliter of (3) Limitations. Federal law restricts gel contains 20 milligrams (mg) (2.0 this drug to use by or on the order of a percent) moxidectin and 125 mg (12.5 licensed veterinarian. percent) praziquantel. [62 FR 37713, July 15, 1997, as amended at 78 (b) Sponsor. See No. 054771 in FR 28825, May 20, 2014] § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 § 520.1452 Moxidectin gel. of this chapter. (a) Specifications. Each milliliter of (d) Conditions of use in horses and gel contains 20 milligrams (2 percent) ponies—(1) Amount. Administer by moxidectin. mouth as a single dose: 0.4 mg (b) Sponsor. See No. 054771 in moxidectin per kilogram and 2.5 mg § 510.600(c) of this chapter. praziquantel per kilogram (2.2 pounds) (c) Special considerations. See § 500.25 body weight. of this chapter. (2) Indications for use. For the treat- (d) Conditions of use in horses and ment and control of large strongyles: ponies—(1) Amount. 0.4 milligram Strongylus vulgaris (adults and L4/L5 ar- moxidectin per kilogram (2.2 pounds) of terial stages), S. edentatus (adult and body weight. tissue stages), Triodontophorus (2) Indications for use. For the treat- brevicauda (adults), and T. serratus ment and control of large strongyles: (adults); small strongyles (adults): Strongylus vulgaris (adults and L4/L5 ar- (Cyathostomum spp., including C. terial stages), S. edentatus (adult and catinatum and C. pateratum; Cylicocyclus tissue stages), Triodontophorus spp., including C. insigne, C. brevicauda (adults), and T. serratus leptostomum, C. nassatus, and C.

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radiatus; Cylicostephanus spp., including § 520.1468 Naproxen. C. calicatus, C. goldi, C. longibursatus, (a) Specifications. Each gram of gran- and C. minutus; Coronocyclus spp., in- ules contains 500 milligrams (mg) (50 cluding C. coronatus, C. labiatus, and C. percent) naproxen. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small (b) Sponsor. See No. 054771 in strongyles: undifferentiated lumenal § 510.600(c) of this chapter. larvae; encysted cyathostomes (late L3 (c) Conditions of use in horses—(1) and L4 mucosal cyathostome larvae); Amount. 10 mg per kilogram of body ascarids: Parascaris equorum (adults and weight twice daily top dressed on feed L4 larval stages); pinworms: Oxyuris for up to 14 consecutive days. equi (adults and L4 larval stages); (2) Indications for use. For the relief of hairworms: Trichostrongylus axei inflammation and associated pain and (adults); large-mouth stomach worms: lameness exhibited with arthritis, as Habronema muscae (adults); horse stom- well as myositis and other soft tissue ach bots: Gasterophilus intestinalis (2nd diseases of the musculoskeletal sys- and 3rd instars) and G. nasalis (3rd tem. instars); and tapeworms: Anoplocephala (3) Limitations. Do not use in horses perfoliata (adults). One dose also sup- intended for human consumption. Fed- presses strongyle egg production for 84 eral law restricts this drug to use by or days. on the order of a licensed veterinarian. (3) Limitations. Do not use in horses intended for human consumption. [78 FR 28825, May 20, 2014] [68 FR 51446, Aug. 27, 2003, as amended at 69 § 520.1484 Neomycin. FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014] (a) Specifications—(1) Each ounce of powder contains 20.3 grams (g) neomy- § 520.1454 Moxidectin solution. cin sulfate (equivalent to 14.2 g neomy- cin base). (a) Specifications. Each milliliter (mL) of solution contains 1 milligram (2) Each milliliter of solution con- (mg) moxidectin. tains 200 milligrams (mg) neomycin (b) Sponsor. See No. 000010 in sulfate (equivalent to 140 mg neomycin § 510.600(c) of this chapter. base). (c) Related tolerances. See § 556.426 of (b) Sponsors. See sponsors in this chapter. § 510.600(c) of this chapter for use as in (d) Special considerations. See § 500.25 paragraph (e) of this section. of this chapter. (1) Nos. 054771 and 054925 for use of (e) Conditions of use in sheep—(1) product described in paragraph (a)(1) as Amount. Administer 1 mL per 11 pounds in paragraph (e)(1) of this section. body weight (1 mL per 5 kilograms) by (2) Nos. 016592, 054771, 058005, and mouth. 061623 for use of product described in (2) Indications for use. For the treat- paragraph (a)(1) as in paragraphs (e)(1) ment and control of the adult and L4 and (e)(2) of this section. larval stages of Haemonchus contortus, (3) Nos. 016592, 054771, 054925, and Teladorsagia circumcincta, T. trifurcata, 058005 for use of product described in Trichostrongylus axei, T. colubriformis, T. paragraph (a)(2) as in paragraph (e)(1) vitrinus, Cooperia curticei, C. oncophora, of this section. Oesophagostomum columbianum, O. (c) Related tolerances. See § 556.430 of venulosum, Nematodirus battus, N. this chapter. filicollis, and N. spathiger. (d) Special labeling considerations. La- (3) Limitations. Sheep must not be beling shall bear the following warning slaughtered for human consumption statements: ‘‘A withdrawal period has within 7 days of treatment. Because a not been established for use in withholding time in milk has not been preruminating calves. Do not use in established for this product, do not use calves to be processed for veal. Use of in female sheep providing milk for more than one product containing neo- human consumption. mycin or failure to follow withdrawal [70 FR 76163, Dec. 23, 2005, as amended at 76 times may result in illegal drug resi- FR 48714, Aug. 9, 2011] dues.’’

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(e) Conditions of use—(1) Cattle, swine, (ii) Indications for use—(A) For the sheep, and goats—(i) Amount. 10 mg per treatment of flea infestations on dogs pound (/lb) of body weight per day (22 and puppies 4 weeks of age and older mg per kilogram (/kg)) in divided doses and 2 lbs of body weight or greater. for a maximum of 14 days. (B) The concurrent use of nitenpyram (ii) Indications for use. For the treat- tablets as in paragraph (d)(1)(i)(B) of ment and control of colibacillosis (bac- this section with either flavored terial enteritis) caused by Escherichia lufenuron tablets as in § 520.1288(c)(1) of coli susceptible to neomycin sulfate. this chapter or flavored milbemycin (iii) Limitations. Discontinue treat- and lufenuron tablets as in ment prior to slaughter as follows: Cat- § 520.1443(d)(1) is indicated to kill adult tle, 1 day; sheep, 2 days; swine and fleas and prevent flea eggs from hatch- goats, 3 days. Federal law restricts this ing. drug to use by or on the order of a li- (2) Cats—(i) Amount—(A) One 11.4-mg censed veterinarian. tablet, as needed, for use as in para- (2) Turkeys—(i) Amount. 10 mg/lb of graph (d)(2)(ii)(A) of this section. body weight per day (22 mg/kg) for 5 (B) One 11.4-mg tablet, once or twice days. weekly, for use as in paragraph (ii) Indications for use. For the control (d)(2)(ii)(B) of this section. of mortality associated with E. coli sus- (ii) Indications for use—(A) For the ceptible to neomycin sulfate in grow- treatment of flea infestations on cats ing turkeys. and kittens 4 weeks of age and older (iii) Limitations. Federal law restricts and 2 lbs of body weight or greater. this drug to use by or on the order of a (B) The concurrent use of nitenpyram licensed veterinarian. tablets as in paragraph (d)(2)(i)(B) of [71 FR 56866, Sept. 28, 2006, as amended at 71 this section with flavored lufenuron FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, tablets as in § 520.1288(c)(2) of this chap- 2013; 78 FR 28825, May 20, 2014; 81 FR 22523, ter is indicated to kill adult fleas and Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016] prevent flea eggs from hatching.

§ 520.1510 Nitenpyram. [68 FR 51906, Aug. 29, 2003, as amended at 80 FR 18776, Apr. 8, 2015] (a) Specifications. Each tablet con- tains 11.4 or 57 milligrams (mg) § 520.1604 Oclacitinib. nitenpyram. (a) Specifications. Each tablet con- (b) Sponsors. See sponsor numbers in tains 3.6, 5.4, or 16 milligrams (mg) of § 510.600(c) of this chapter: oclacitinib as oclacitinib maleate. (1) No. 058198 for use as in paragraphs (b) Sponsor. See No. 054771 in (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of § 510.600(c) of this chapter. this section. (c) Conditions of use—(1) Amount. Ad- (2) No. 051311 for use as in paragraphs minister orally 0.18 to 0.27 mg/per (d)(1)(i)(B) and (d)(1)(ii)(B) of this sec- pound of body weight (0.4 to 0.6 mg/kg tion. body weight) twice daily for up to 14 (c) Special considerations. The concur- days; then administered once daily for rent use of nitenpyram tablets and fla- maintenance therapy. vored milbemycin/lufenuron tablets as (2) Indications for use. For control of in paragraph (d)(1)(ii)(B) of this section pruritus associated with allergic der- shall be by or on the order of a licensed matitis and control of atopic derma- veterinarian. titis in dogs at least 12 months of age. (d) Conditions of use—(1) Dogs—(i) (3) Limitations. Federal law restricts Amount—(A) One 11.4-mg tablet for this drug to use by or on the order of a dogs weighing less than 25 pounds (lb) licensed veterinarian. or one 57-mg tablet for dogs weighing more than 25 lb, as needed, for use as in [78 FR 42007, July 15, 2013] paragraph (d)(1)(ii)(A) of this section. (B) One 11.4-mg tablet for dogs weigh- § 520.1615 Omeprazole. ing less than 25 lb or one 57 mg tablet (a) Specifications. Each gram of paste for dogs weighing more than 25 lbs, contains 0.37 gram omeprazole. once or twice weekly, for use as in (b) Sponsor. See No. 050604 in paragraph (d)(1)(ii)(B) of this section. § 510.600(c) of this chapter.

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(c) Special considerations. When la- (c) Special considerations. Federal law beled for use as in paragraph (d)(2)(i) of restricts this drug to use by or on the this section, product labeling shall order of a licensed veterinarian. Fed- bear: ‘‘Federal law restricts this drug eral law prohibits the extralabel use of to use by or on the order of a licensed this drug in food-producing animals. veterinarian.’’ (d) Conditions of use—(1) Dogs—(i) (d) Conditions of use in horses—(1) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/ Amount—(i) For treatment of gastric kg) of body weight once daily. ulcers, 1.8 milligrams per pound (mg/lb) (ii) Indications for use. For the treat- of body weight (4 milligrams per kilo- ment of urinary tract infections (cys- gram (mg/kg)) once daily for 4 weeks. titis) in dogs caused by susceptible For prevention of recurrence of gastric strains of Staphylococcus ulcers, 0.9 mg/lb of body weight (2 mg/ pseudintermedius, Proteus mirabilis, Esch- kg) once daily for at least an addi- erichia coli, and Enterococcus faecalis tional 4 weeks. and skin and soft tissue infections (ii) For prevention of gastric ulcers (wounds and abscesses) in dogs caused using the premarked syringe, one dose by susceptible strains of Staphylococcus per day for 8 or 28 days. Each dose de- pseudintermedius, Staphylococcus aureus, livers at least 1 mg/kg of body weight. coagulase-positive staphylococci, Horses over 1,200 lb body weight should Pasteurella multocida, Proteus mirabilis, receive two doses per day. Pseudomonas spp., Klebsiella (2) Indications for use. (i) For treat- pneumoniae, E. coli, Enterobacter spp., ment and prevention of recurrence of Citrobacter spp., E. faecalis, b-hemolytic gastric ulcers in horses and foals 4 streptococci (Group G), and Strepto- weeks of age and older. coccus equisimilis. (ii) For prevention of gastric ulcers (2) Cats—(i) Amount. 3.4 mg/lb (7.5 mg/ in horses. kg) of body weight once daily. (3) Limitations. Do not use in horses intended for human consumption. (ii) Indications for use. For the treat- ment of skin infections (wounds and [69 FR 13220, Mar. 22, 2004, as amended at 71 abscesses) in cats caused by susceptible FR 59374, Oct. 10, 2006] strains of S. aureus, E. coli, and P. multocida. § 520.1616 Orbifloxacin tablets. (a) Specifications. Each tablet con- [75 FR 26646, May 12, 2010] tains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin. § 520.1628 Oxfendazole powder and pellets. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (a) Specifications—(1) Powder for sus- (c) Conditions of use in dogs and cats— pension. Each gram of powder contains (1) Amount. 2.5 to 7.5 mg per kilogram 7.57 percent oxfendazole. body weight once daily. (2) Pellets. Each gram of pellets con- (2) Indications for use. For manage- tains 6.49 percent oxfendazole. ment of diseases associated with bac- (b) Sponsor. See No. 054771 in teria susceptible to orbifloxacin. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Amount. 10 this drug to use by or on the order of a milligrams per kilogram of body licensed veterinarian. Federal law pro- weight. hibits the extralabel use of this drug in (2) Indications for use. The drug is food producing animals. used in horses for removal of the fol- [71 FR 14643, Mar. 23, 2006, as amended at 75 lowing gastrointestinal worms: Large FR 26646, May 12, 2010] roundworms (Parascaris equorum), ma- ture and immature pinworms (Oxyuris § 520.1618 Orbifloxacin suspension. equi), large strongyles (Strongylus (a) Specifications. Each milliliter of edentatus, Strongylus vulgaris, and suspension contains 30 milligrams (mg) Strongylus equinus), and small orbifloxacin. strongyles. (b) Sponsor. See No. 000061 in (3) Limitations—(i) Powder for suspen- 510.600(c) of this chapter. sion. For gravity administration via

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stomach tube or for positive adminis- (4) Conditions of use—(i) Amount. 4.5 tration via stomach tube and dose sy- milligrams per kilogram of body ringe. Discard unused portions of sus- weight (2.05 milligrams per pound). pension after 24 hours. Mix drug ac- (ii) Indications for use. The drug is cording to directions prior to use. Ad- used in cattle for the removal and con- minister drug with caution to sick or trol of the following worms: lungworms debilitated horses. Not for use in (Dictyocaulus viviparus—adult, L4); horses intended for food. Federal law stomach worms: barberpole worms restricts this drug to use by or on the (Haemonchus contortus and H. placei— order of a licensed veterinarian. adult), small stomach worms (ii) Pellets. The drug is given by sprin- (Trichostrongylus axei—adult), brown kling on the grain portion of the ra- stomach worms (Ostertagia ostertagi— tion. Withholding feed or water prior adult, L4, inhibited L4); intestinal to administration is not necessary. Ad- worms; nodular worms minister drug with caution to sick or (Oesophagostomum radiatum—adult), debilitated horses. Not for use in hookworms (Bunostomum horses intended for food. Consult your phlebotomum—adult), small intestinal veterinarian for assistance in the diag- worms (Cooperia punctata, C. oncophora, nosis, treatment, and control of para- and C. mcmasteri—adult, L4); and tape- sitism. worms (Moniezia benedeni—adult). (iii) Limitations. For use in cattle [44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, only. Treatment may be repeated in 4 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, to 6 weeks. Cattle must not be slaugh- Feb. 13, 1996; 78 FR 28825, May 20, 2014] tered until 11 days after treatment. Do not use in female dairy cattle of breed- § 520.1629 Oxfendazole paste. ing age. Consult a veterinarian for as- (a)(1) Specifications. Each gram of sistance in the diagnosis, treatment, paste contains 0.375 gram oxfendazole and control of parasitism. (37.5 percent). [49 FR 38250, Sept. 28, 1984, as amended at 58 (2) Sponsor. See No. 054771 in FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, § 510.600(c) of this chapter. 1996; 78 FR 28825, May 20, 2014] (3) Conditions of use—(i) Amount. 10 milligrams per kilogram (2.2 pounds) of § 520.1630 Oxfendazole suspension. body weight. (a) Specifications. Each milliliter of (ii) Indications for use. The drug is suspension contains: used in horses for removal of the fol- (1) 90.6 milligrams (mg) oxfendazole lowing gastrointestinal worms: Large (9.06 percent). roundworms (Parascaris equorum), ma- (2) 225.0 mg oxfendazole (22.5 percent). ture and 4th stage larvae pinworms (b) Sponsor. See Nos. 000010 and 054771 (Oxyuris equi), large strongyles in § 510.600(c) of this chapter. (Strongylus edentatus, S. vulgaris, and S. (c) Related tolerances. See § 556.495 of equinus), and small strongyles. this chapter. (iii) Limitations. Horses maintained (d) Special considerations. See § 500.25 on premises where reinfection is likely of this chapter. If labeled for adminis- to occur should be retreated in 6 to 8 tration by stomach tube: Federal law weeks. Withholding feed or water prior restricts this drug to use by or on the to use is unnecessary. Administer drug order of a licensed veterinarian. with caution to sick or debilitated (e) Conditions of use—(1) Horses. Use horses. Not for use in horses intended the product described in paragraph for food. Consult your veterinarian for (a)(1) of this section as follows: assistance in the diagnosis, treatment, (i) Amount. 10 mg per kilogram (/kg) and control of parasitism. of body weight by stomach tube or dose (b)(1) Specifications. Each gram of syringe. Horses maintained on prem- paste contains 185 milligrams of ises where reinfection is likely to occur oxfendazole (18.5 percent). should be retreated in 6 to 8 weeks. (2) Sponsor. See No. 054771 in (ii) Indications for use. For removal of § 510.600(c) of this chapter. large roundworms (Parascaris equorum), (3) Related tolerances. See § 556.495 of mature and 4th stage larvae pinworms this chapter. (Oxyuris equi), large strongyles

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(Strongylus edentatus, S. vulgaris, and S. adult and 4th stage larvae; large equinus), and small strongyles. strongyles (Strongylus edentatus, S. (iii) Limitations. Withholding feed or vulgaris, and S. equinus); and small water prior to use is unnecessary. Ad- strongyles. minister drug with caution to sick or (3) Limitations. Horses maintained on debilitated horses. Do not use in horses premises where reinfection is likely to intended for human consumption. occur should be retreated in 6 to 8 (2) Cattle. Use the products described weeks. Withholding feed or water be- in paragraphs (a)(1) and (a)(2) of this fore use is unnecessary. Administer section as follows: with caution to sick or debilitated (i) Amount. 4.5 mg/kg of body weight horses. Not for use in horses intended by dose syringe. Treatment may be re- for food. Do not administer to mares peated in 4 to 6 weeks. during the last month of pregnancy. (ii) Indications for use. For the re- Trichlorfon is a cholinesterase inhib- moval and control of: lungworms itor. Do not use this product in ani- (Dictyocaulus viviparus—adult, L4); mals simultaneously with, or within a stomach worms: barberpole worms few days before or after treatment with (Haemonchus contortus and H. placei— or exposure to, cholinesterase-inhib- adult), small stomach worms iting drugs, pesticides, or chemicals. (Trichostrongylus axei—adult), brown Consult your veterinarian for assist- stomach worms (Ostertagia ostertagi— ance in the diagnosis, treatment, and adult, L4, inhibited L4); intestinal control of parasitism. worms; nodular worms [50 FR 50291, Dec. 10, 1985, as amended at 61 (Oesophagostomum radiatum—adult), FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, hookworms (Bunostomum 2014] phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, § 520.1638 Oxibendazole. and C. surnabada—adult, L4), and tape- (a) Specifications—(1) Each gram of worms (Moniezia benedeni—adult). paste contains 227 milligrams (mg) (22.7 (iii) Limitations. Cattle must not be percent) oxibendazole. slaughtered until 7 days after treat- (2) Each milliliter of suspension con- ment. Because a withdrawal time in tains 100 mg (10 percent) oxibendazole. milk has not been established, do not (b) Sponsor. See No. 054771 in use in female dairy cattle of breeding § 510.600(c) of this chapter. age. (c) Special considerations—(1) See [55 FR 46943, Nov. 8, 1990, as amended at 56 § 500.25 of this chapter. FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; (2) Suspension product described in 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, paragraph (a)(2) of this section shall be 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, labeled: ‘‘Federal law restricts this May 20, 2014] drug to use by or on the order of a li- censed veterinarian.’’ § 520.1631 Oxfendazole and trichlorfon (d) Conditions of use in horses—(1) paste. Amount. For uses other than for (a) Specifications. Each gram of paste threadworms (Strongyloides westeri), 10 contains 28.5 milligrams oxfendazole mg oxibendazole per kilogram (/kg) and 454.5 milligrams trichlorfon. body weight; for threadworms (b) Sponsor. See 054771 in § 510.600(c) of (Strongyloides westeri), 15 mg/kg. Horses this chapter. maintained on premises where reinfec- (c) Conditions of use—(1) Amount. 2.5 tion is likely to occur should be re- milligrams of oxfendazole and 40 milli- treated in 6 to 8 weeks. Administer sus- grams of trichlorfon per kilogram of pension product by stomach tube in 3 body weight. to 4 pints of warm water, or by top (2) Indications for use. The drug is dressing or mixing into a portion of the used in horses for removal of bots normal grain ration. (Gasterophilus intestinalis, 2nd and 3rd (2) Indications for use. For removal instars; G. nasalis, 3rd instar) and the and control of large strongyles following gastrointestinal worms: (Strongylus edentatus, S. equinus, S. Large roundworms (Parascaris vulgaris); small strongyles (genera equorum), pinworms (Oxyuris equi), Cylicostephanus, Cylicocyclus,

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Cyathostomum, Triodontophorus, § 520.1660b Oxytetracycline hydro- Cylicodontophorus, and Gyalocephalus); chloride capsules. large roundworms (Parascaris equorum); (a) Specifications. The drug is in cap- pinworms (Oxyuris equi) including var- sule form with each capsule containing ious larval stages; and threadworms 125 or 250 milligrams of oxytetracycline (Strongyloides westeri). hydrochloride. Oxytetracycline is the (3) Limitations. Do not use in horses antibiotic substance produced by intended for human consumption. growth of Streptomyces rimosus or the [78 FR 28825, May 20, 2014] same antibiotic substance produced by any other means. § 520.1660 Oxytetracycline. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.1660a Oxytetracycline and carbomycin. (c) Conditions of use. (1) It is used in dogs and cats for the treatment of bac- (a) Specifications. (1) Oxytetracycline: terial pneumonia caused by Brucella The antibiotic substance produced by bronchiseptica, tonsilitis caused by growth of Streptomyces rimosus or the Streptococcus hemolyticus, bacterial en- same antibiotic substance produced by teritis caused by Escherichia coli, uri- any other means. nary tract infections caused by Esch- (2) Carbomycin: The antibiotic sub- erichia coli, and wound infections stance produced by growth of caused by Staphylococcus aureus. Streptomyces halstedii or the same anti- (2) The drug is administered orally to biotic substance produced by any other dogs and cats at a dosage level of 25–50 means. (b) Sponsor. See No. 054771 in milligrams per pound of body weight § 510.600(c) of this chapter. per day in divided doses at 12-hour in- (c) Special considerations. The quan- tervals. The drug can be used for con- tities of oxytetracycline in paragraph tinuation of compatible antibiotic (e) of this section refer to the activity therapy following parenteral oxytetra- of oxytetracycline hydrochloride and cycline administration where rapidly the quantities of carbomycin listed attained, sustained antibiotic blood refer to the activity of an appropriate levels are required. The duration of standard. treatment required to obtain favorable (d) Related tolerances. See §§ 556.110 response will depend to some extent on and 556.500 of this chapter. the severity and degree of involvement (e) Conditions of use. It is used as oxy- and the susceptibility of the infectious tetracycline hydrochloride plus agent. Clinical response to antibiotic carbomycin base in drinking water of therapy usually occurs within 48 to 72 chickens as follows: hours. If improvement is not observed (1) Amount. Administer 1.0 gram of within that period, the diagnosis and oxytetracycline and 1.0 gram course of treatment should be reconsid- carbomycin per gallon for not more ered. To assure adequate treatment, than 5 days. administration of the drug should con- (2) Indications for use. As an aid in the tinue for at least 48 hours following fa- prevention and treatment of com- vorable clinical response. plicated chronic respiratory disease (3) Federal law restricts this drug to (air-sac infection) caused by Myco- use by or on the order of a licensed vet- plasma gallisepticum and secondary bac- erinarian. terial organisms associated with chron- [40 FR 13838, Mar. 27, 1975, as amended at 78 ic respiratory disease such as E. coli. FR 28825, May 20, 2014] (3) Limitations. Not for use in chick- ens producing eggs for human con- § 520.1660c Oxytetracycline hydro- sumption. Withdraw 24 hours before chloride tablets/boluses. slaughter. Federal law restricts this (a) Specifications. Each tablet or bolus drug to use by or on the order of a li- contains 250, 500, or 1,000 milligrams of censed veterinarian. oxytetracycline hydrochloride. [40 FR 13838, Mar. 27, 1975, as amended at 78 (b) Sponsors. For sponsors in FR 28825, May 20, 2014; 81 FR 94989, Dec. 27, § 510.600(c) of this chapter: See 000010 2016] for use of 500 and 1,000 milligram

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boluses. See No. 054771 for use of 250 (2) Each 4.43 grams of powder con- and 500 milligram tablets. tains 1 gram of OTC HCl (packets: 4 (c) Tolerances. See § 556.500 of this and 16 oz.). chapter. (3) Each 1.32 grams of powder con- (d) Conditions of use in beef and dairy tains 1 gram of OTC HCl (packets: 2.39, cattle—(1)(i) Amount. 250 milligrams per 4.78, and 9.55 oz.; jars: 2.25 lbs.; and 100 pounds of body weight every 12 pails: 4.5 lbs.). hours (5 milligrams per pound of body (4) Each 2.73 grams of powder con- weight daily in two doses). tains 1 gram of OTC HCl (packets: 2.46 (ii) Indications for use. For control of and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). bacterial enteritis caused by Salmonella (5) Each 4.2 grams of powder contains typhimurium and Escherichia coli 1 gram of OTC HCl (packets: 3.8 and (colibacillosis) and bacterial pneu- 15.2 oz; pails: 4.74 and 23.7 lb). monia (shipping fever complex, (6) Each 1.32 grams of powder con- pasteurellosis) caused by Pasteurella tains 1 gram of OTC HCl (packet: 4.78 multocida. oz.; pail: 5 lb). Each 2.73 grams of pow- (2)(i) Amount. 500 milligrams per 100 der contains 1 gram of OTC HCl (pack- pound of body weight every 12 hours (10 et: 9.87 oz). milligrams per pound of body weight (7) Each 1.32 grams of powder con- daily in two doses). tains 1 gram of OTC HCl (packet: 4.78 (ii) Indications for use. For treatment and 9.6 oz.; pails: 2 and 5 lb); each 18.1 of bacterial enteritis caused by Sal- grams of powder contains 1 gram of monella typhimurium and Escherichia coli OTC HCl (packet: 6.4 oz.; pails: 2 and 5 (colibacillosis) and bacterial pneu- lb). monia (shipping fever complex, (8) Each 135.5-gram packet (4.78 pasteurellosis) caused by Pasteurella ounce) contains 102.4 grams of OTC multocida. HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl. (3) Limitations. Dosage should con- (9) Each 2.73 grams of powder con- tinue until the animal returns to nor- tains 1 gram of OTC HCl (packets: 9.87 mal and for 24 hours to 48 hours after and, 19.75 oz, and 3.91 lb; pails: 3.09 and symptoms have subsided. Treatment 5 lb). should not exceed 4 consecutive days. (10) Each 2.73 grams of powder con- Do not exceed 500 milligrams per 100 tains 1 gram of OTC HCl (packets: 9.87 pounds of body weight every 12 hours and 19.74 oz; pails: 5 lb). (10 milligrams per pound daily). For (b) Sponsor. See sponsor numbers in sponsor No. 054771: Discontinue treat- § 510.600(c) of this chapter as follows: ment 7 days prior to slaughter. Not for (1) No. 054771 for use of OTC HCl con- use in lactating dairy cattle. A with- centrations in paragraphs (a)(1), (a)(2), drawal period has not been established and (a)(3) of this section in chickens, for this product in preruminating turkeys, swine, cattle, sheep, and calves. Do not use in calves to be proc- honey bees. essed for veal. (2) No. 016592 for use of OTC HCl con- [46 FR 32440, June 23, 1981, as amended at 50 centration in paragraph (a)(4) of this FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, section in chickens, turkeys, and 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, swine. May 20, 2014] (3) No. 066104 for use of OTC HCl con- centration in paragraph (a)(5) of this § 520.1660d Oxytetracycline powder. section in turkeys and chickens. (a) Specifications. The drug is a solu- (4) No. 057561 for use of OTC HCl con- ble powder distributed in packets or centration in paragraph (a)(6) of this pails having several concentrations of section in chickens, turkeys, and oxytetracycline hydrochloride (inde- swine. pendent of the various net weights) as (5) No. 061623 for use of OTC HCl con- follows: centration in paragraph (a)(7) of this (1) Each 18.14 grams of powder con- section in chickens, turkeys, swine, tains 1 gram of oxytetracycline hydro- cattle, sheep, and honeybees. chloride (OTC HCl) (packets: 4, 6.4, and (6) No. 069254 for use of OTC HCl con- 16 oz.). centrations in paragraph (a)(8) of this

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section in chickens, turkeys, swine, (B)(1) Amount. Administer 400 milli- cattle, sheep, and honey bees. grams/gallon for 7 to 14 days. Not to be (7) No. 061623 for use of OTC HCl con- used for more than 14 consecutive days. centration in paragraph (a)(9) of this (2) Indications for use. Control of in- section in chickens, turkeys, and fectious synovitis caused by Myco- swine. plasma synoviae susceptible to oxytet- (c) Related tolerances. See § 556.500 of racycline. this chapter. (3) Do not use in birds producing eggs (d) Conditions of use. (1) It is used in for human consumption. Withdraw 5 drinking water as follows: days prior to slaughter those products sponsored by Nos. 054771 and 061623 in (i) Chickens—(A)(1) Amount. Admin- § 510.600(c) of this chapter. Withdraw 4 ister 200 to 400 milligrams/gallon for 7 days prior to slaughter those products to 14 days. Not to be used for more sponsored by No. 054628. Zero-day with- than 14 consecutive days. drawal for those products sponsored by (2) Indications for use. Control of in- Nos. 057561 and 069254. Federal law re- fectious synovitis caused by Myco- stricts this drug to use by or on the plasma synoviae susceptible to oxytet- order of a licensed veterinarian. racycline. (C)(1) Amount. Administer 25 milli- (3) Do not use in birds producing eggs grams per pound of body weight daily for human consumption. Federal law for 7 to 14 days. Not to be used for more restricts this drug to use by or on the than 14 consecutive days. order of a licensed veterinarian. (2) Indications for use. Growing tur- (B)(1) Amount. Administer 400 to 800 keys. Control of complicating bacterial milligrams/gallon for 7 to 14 days. Not organisms associated with bluecomb to be used for more than 14 consecutive (transmissible enteritis, coronaviral days. enteritis) susceptible to oxytetra- (2) Indications for use. Control of cycline. chronic respiratory disease (CRD) and (3) Do not use in birds producing eggs air sac infections caused by Myco- for human consumption. Withdraw 5 plasma gallisepticum and E. coli suscep- days prior to slaughter those products tible to oxytetracycline; control of sponsored by Nos. 054771 and 061623 in fowl cholera caused by Pasteurella § 510.600(c) of this chapter. Withdraw 4 multocida susceptible to oxytetra- days prior to slaughter those products cycline. sponsored by No. 054628. Zero-day with- (3) Do not use in birds producing eggs drawal for those products sponsored by for human consumption. Federal law Nos. 057561 and 069254. Federal law re- restricts this drug to use by or on the stricts this drug to use by or on the order of a licensed veterinarian. order of a licensed veterinarian. (iii) Swine—(A) Amount. Administer (ii) Turkeys—(A)(1) Amount. Admin- 10 milligrams per pound of body weight ister 200 to 400 milligrams/gallon for 7 daily for up to 14 days. Do not use for to 14 days. Not to be used for more more than 14 consecutive days. than 14 consecutive days. (B) Indications for use. Control and (2) Indications for use. Control of treatment of bacterial enteritis caused hexamitiasis caused by Hexamita by Escherichia coli and Salmonella meleagridis susceptible to oxytetra- choleraesuis and bacterial pneumonia cycline. caused by Pasteurella multocida suscep- (3) Do not use in birds producing eggs tible to oxytetracycline. For breeding for human consumption. Withdraw 5 swine: Control and treatment of lepto- days prior to slaughter those products spirosis (reducing the incidence of sponsored by Nos. 054771 and 061623 in abortions and shedding of leptospira) § 510.600(c) of this chapter. Withdraw 4 caused by Leptospira pomona suscep- days prior to slaughter those products tible to oxytetracycline. sponsored by No. 054628. Zero-day with- (C) Withdraw zero days prior to drawal for those products sponsored by slaughter those products sponsored by Nos. 057561 and 069254. Federal law re- Nos. 054771, 057561, 061623, and 069254 in stricts this drug to use by or on the § 510.600(c) of this chapter. Withdraw 4 order of a licensed veterinarian. days prior to slaughter those products

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sponsored by No. 054628. Federal law re- stricts this drug to use by or on the stricts this drug to use by or on the order of a licensed veterinarian. order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975] (iv) Calves, beef cattle, and nonlac- tating dairy cattle—(A) Amount. Admin- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 520.1660d, see the List of ister 10 milligrams per pound of body CFR Sections Affected, which appears in the weight daily for up to 14 days. Do not Finding Aids section of the printed volume use for more than 14 consecutive days. and at www.fdsys.gov. (B) Indications for use. Control and treatment of bacterial enteritis caused § 520.1696 Penicillin. by E. coli and bacterial pneumonia § 520.1696a [Reserved] (shipping fever complex) caused by P. multocida susceptible to oxytetra- § 520.1696b Penicillin G powder. cycline. (a) Specifications. Each gram of pow- (C) Withdraw 5 days prior to slaugh- der contains penicillin G potassium ter. A milk discard period has not been equivalent to 1.54 million units of peni- established for this product in lac- cillin G. tating dairy cattle. Do not use in fe- (b) Sponsors. See Nos. 010515, 016592, male dairy cattle 20 months of age or 054771, 061623 and 076475 in § 510.600(c) of older. Federal law restricts this drug to this chapter. use by or on the order of a licensed vet- (c) Related tolerances. See § 556.510 of erinarian. this chapter. (v) Sheep—(A) Amount. Administer 10 (d) Conditions of use in turkeys— (1) milligrams per pound of body weight Amount. 1,500,000 units per gallon daily for up to 14 days. Not to be used drinking water for 5 days. for more than 14 consecutive days. (2) Indications for use. Treatment of (B) Indications for use. Control and erysipelas caused by Erysipelothrix treatment of bacterial enteritis caused rhusiopathiae. (3) Limitations. Discontinue treat- by E. coli and bacterial pneumonia ment at least 1 day prior to slaughter. (shipping fever complex) caused by P. Not for use in turkeys producing eggs multocida susceptible to oxytetra- for human consumption. Federal law cycline. restricts this drug to use by or on the (C) Withdraw 5 days prior to slaugh- order of a licensed veterinarian. ter. Federal law restricts this drug to use by or on the order of a licensed vet- [57 FR 37326, Aug. 18, 1992, as amended at 59 erinarian. FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, (2) It is used in the food of honey bees Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR as follows: 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; (i) Amount. 200 milligrams per colony, 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, administered via either a 1:1 sugar 2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, syrup (equal parts of sugar and water May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016] weight to weight) or dusting with a powdered sugar mixture. The drug is § 520.1696c Penicillin V powder. administered in 3 applications of sugar (a) Specifications. When reconstituted, syrup or 3 dustings at 4- to 5-day inter- each milliliter contains 25 milligrams vals. (40,000 units) of penicillin V. (ii) Indications for use. For control of (b) Sponsor. See No. 050604 in American foulbrood caused by § 510.600(c) of this chapter. Paenibacillus larvae and European (c) Conditions of use in dogs and cats— foulbrood caused by Streptococcus (1) Amount. 10 to 15 milligrams per pluton susceptible to oxytetracycline. pound of body weight every 6 to 8 (iii) The drug should be fed early in hours. the spring or fall and consumed by the (2) Indications for use. Treatment of bees before main honey flow begins to respiratory, urogenital, skin, and soft avoid contamination of production tissue infections and septicemia caused honey. Remove at least 6 weeks prior by pathogens susceptible to penicillin to main honey flow. Federal law re- V potassium.

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(3) Limitations. Federal law restricts 1 gram (g) of phenylbutazone. Each this drug to use by or on the order of a bolus contains 1, 2, or 4 gram g of licensed veterinarian. phenylbutazone. [57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. (b) Sponsors. See sponsor numbers in 15, 1992; 77 FR 20988, Apr. 9, 2012; 78 FR 28826, § 510.600(c) of this chapter, as follows: May 20, 2014] (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in § 520.1696d Penicillin V tablets. dogs and horses. (a) Specifications. Each tablet con- (2) Nos. 054628 and 069043 for use of tains penicillin V potassium equivalent 100- or 200-mg or 1-g tablets in dogs and to 125 milligrams (200,000 units) or 250 horses. milligrams (400,000 units) of penicillin (3) Nos. 054771 and 061623 for use of V. 100-mg or 1-g tablets in dogs and (b) Sponsors. See Nos. 050604 and horses. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats— (4) [Reserved] (1) Amount. 10 to 15 milligrams per (5) No. 000143 for use of 1-g tablets in pound of body weight every 6 to 8 horses. hours. (6) No. 058829 for use of 100-mg or 1-g (2) Indications for use. Treatment of tablets in dogs and horses. respiratory, urogenital, skin and soft (c) Conditions of use—(1) Dogs—(i) tissue infections and septicemia caused Amount. 20 mg per pound of body by pathogens susceptible to penicillin weight daily. V potassium. (ii) Indications for use. For the relief (3) Limitations. Federal law restricts of inflammatory conditions associated this drug to use by or on the order of a with the musculoskeletal system. licensed veterinarian. (iii) Limitations. Federal law restricts [57 FR 37327, Aug. 18, 1992, as amended at 59 this drug to use by or on the order of a FR 58775, Nov. 15, 1994; 78 FR 28826, May 20, licensed veterinarian. 2014] (2) Horses—(i) Amount. 1 to 2 g per 500 § 520.1705 Pergolide. pounds of body weight daily. (ii) Indications for use. For the relief (a) Specifications. Each tablet con- of inflammatory conditions associated tains 1 milligram (mg) peroglide (as with the musculoskeletal system. pergolide mesylate). (b) Sponsor. See No. 000010 in (iii) Limitations. Do not use in horses § 510.600(c) of this chapter. intended for human consumption. Fed- (c) Conditions of use in horses—(1) eral law prohibits the use of this drug Amount. Administer orally at a start- in female dairy cattle 20 months of age ing dose of 2 micrograms/kilograms (μ/ or older. Federal law restricts this drug kg) once daily. Dosage may be adjusted to use by or on the order of a licensed to effect, not to exceed 4 μg/kg daily. veterinarian. (2) Indications for use. For the control [73 FR 8192, Feb. 13, 2008, as amended at 74 of clinical signs associated with Pitui- FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, tary Pars Intermedia Dysfunction 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, (Equine Cushing’s Disease). Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR (3) Limitations. Federal law restricts 17607, Mar. 30, 2016] this drug to use by or on the order of a licensed veterinarian. § 520.1720b Phenylbutazone granules. [77 FR 15960, Mar. 19, 2012, as amended at 81 (a) Specifications. Each package of FR 22523, Apr. 18, 2016] granules contains 1 or 8 grams of phenylbutazone. § 520.1720 Phenylbutazone oral dosage forms. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. § 520.1720a Phenylbutazone tablets (1) No. 000061 for 8-gram package. and boluses. (2) No. 059320 for 1-gram package. (a) Specifications. Each tablet con- (c) Conditions of use in horses—(1) tains 100, 200, or 400 milligrams (mg), or Amount. Administer 1 to 2 grams per

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500 pounds of body weight, not to ex- (c) Conditions of use in horses—(1) ceed 4 grams, daily as required. by add- Amount. 1 to 2 grams of phenylbutazone ing to a portion of the usual grain ra- per 500 pounds of body weight, not to tion. exceed 4 grams daily. (2) Indications for use. For the treat- (2) Indications for use. For relief of in- ment of inflammatory conditions asso- flammatory conditions associated with ciated with the musculoskeletal sys- the musculoskeletal system of horses. tem. (3) Limitations. Do not use in horses (3) Limitations. Do not use in horses intended for human consumption. Fed- intended for human consumption. Fed- eral law prohibits the use of this drug eral law prohibits the use of this drug in female dairy cattle 20 months of age in female dairy cattle 20 months of age or older. Federal law restricts this drug or older. Federal law restricts this drug to use by or on the order of a licensed to use by or on the order of a licensed veterinarian. veterinarian. [50 FR 13561, Apr. 5, 1985, as amended at 50 [78 FR 28826, May 20, 2014] FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, § 520.1720c Phenylbutazone paste. 2003; 78 FR 28826, May 20, 2014] (a) Specifications—(1) Each gram of § 520.1720e Phenylbutazone powder. paste contains 0.2 grams phenylbutazone. (a) Specifications—(1) Each 1.15 grams (2) Each gram of paste contains 0.35 (g) of powder contains 1 g grams phenylbutazone. phenylbutazone. (b) Sponsors. See sponsor numbers in (2) Each 10 g of powder contains 1 g § 510.600(c) of this chapter. phenylbutazone. (1) No. 000061 for use of product de- (b) Sponsors. See sponsor numbers in scribed in paragraph (a)(1) of this sec- § 510.600(c) of this chapter. tion. (1) No. 027053 for use of product de- (2) No. 017030 for use of product de- scribed in paragraph (a)(1) of this sec- scribed in paragraph (a)(2) of this sec- tion. tion. (2) No. 057699 for use of product de- (c) Conditions of use in horses—(1) scribed in paragraph (a)(2) of this sec- Amount. 1 to 2 grams of phenylbutazone tion. per 500 pounds of body weight, not to (c) Conditions of use in horses—(1) exceed 4 grams daily. Amount. Administer 1 to 2 g (1 to 2 level (2) Indications for use. For relief of in- scoops, using the scoop provided) per flammatory conditions associated with 500 pounds of body weight on a small the musculoskeletal system. amount of palatable feed, not exceed 4 (3) Limitations. Do not use in horses g per animal daily. intended for human consumption. Fed- (2) Indications for use. For the relief of eral law prohibits the use of this drug inflammatory conditions associated in female dairy cattle 20 months of age with the musculosketetal system. or older. Federal law restricts this drug (3) Limitations. Do not use in horses to use by or on the order of a licensed intended for human consumption. Fed- veterinarian. eral law prohibits the extralabel use of [45 FR 84762, Dec. 23, 1980, as amended at 58 this product in female cattle 20 months FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, of age or older. Federal law restricts 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, this drug to use by or on the order of a July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR licensed veterinarian. 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 FR 74020, Dec. 15, 2014] [72 FR 27956, May 18, 2007]

§ 520.1720d Phenylbutazone gel. § 520.1760 Phenylpropanolamine. (a) Specifications. Each 30 grams of gel (a) Specifications. Each chewable tab- contains 4 grams of phenylbutazone. let contains 25, 50, or 75 milligram (mg) (b) Sponsor. See No. 061623 in phenylpropanolamine hydrochloride. § 510.600(c) of this chapter. require bio- (b) Sponsors. See No. 055246 in equivalency and safety information. § 510.600(c) of this chapter.

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(c) Conditions of use in dogs—(1) stomach tube or dose syringe after Amount. Administer 2 mg/kg of body withholding feed overnight or for 8 to weight twice daily. 10 hours. (2) Indications for use. For the control (2) Indications for use. For removing of urinary incontinence due to urethral ascarids (large roundworms, Parascaris sphincter hypotonus in dogs. equorum), bots (Gastrophilus spp.), small (3) Limitations. Federal law restricts strongyles, large strongyles (Strongyles this drug to use by or on the order of a spp.), and pinworms (Oxyuris equi). licensed veterinarian. (3) Limitations. Do not use in horses [77 FR 15961, Mar. 19, 2012] intended for human consumption. Fed- eral law restricts this drug to use by or § 520.1780 Pimobendan. on the order of a licensed veterinarian. (a) Specifications. Each chewable tab- [45 FR 52781, Aug. 8, 1980, as amended at 78 let contains 1.25, 2.5, 5, or 10 milligrams FR 28826, May 20, 2014] (mg) pimobendan. (b) Sponsor. See No. 000010 in § 520.1802b Piperazine-carbon disul- § 510.600(c) of this chapter. fide complex boluses. (c) Conditions of use in dogs—(1) Amount. Administer orally at a total (a) Specifications. Each bolus contains daily dose of 0.23 mg per pound (0.5 mg 20 grams of piperazine-carbon disulfide per kilogram) body weight, using a complex. suitable combination of whole or half (b) Sponsor. See No. 054771 in tablets. The total daily dose should be § 510.600(c) of this chapter. divided into two portions administered (c) Conditions of use in horses and approximately 12 hours apart. ponies—(1) Amount. For removal of (2) Indications for use. For the man- ascarids and small strongyles, 1 bolus agement of the signs of mild, mod- (20 grams) per 500 pounds body weight; erate, or severe (modified New York removal of large strongyles, pinworms, Heart Association Class II, III, or IV) and bots, 1 bolus per 250 pounds body congestive heart failure due to atrio- weight. ventricular valvular insufficiency or (2) Indications for use. For removing dilated cardiomyopathy; for use with ascarids (large roundworms, Parascaris concurrent therapy for congestive equorum), large strongyles (Strongylus heart failure as appropriate on a case- spp.) bots (Gastrophilus spp.), small by-case basis. strongyles, and pinworms (Oxyuris (3) Limitations. Federal law restricts equi). this drug to use by or on the order of a (3) Limitations. Withhold feed over- licensed veterinarian. night or for 8 to 10 hours. Give water [72 FR 27733, May 17, 2007, as amended at 79 just before and/or after treatment. Re- FR 18158, Apr. 1, 2014] sume regular feeding 4 to 6 hours after treatment. Treatment of debilitated or § 520.1802 Piperazine-carbon disulfide anemic animals is contraindicated. Do complex oral dosage forms. not administer to animals that are or § 520.1802a Piperazine-carbon disul- were recently affected with colic, diar- fide complex suspension. rhea, or infected with a serious infec- tious disease. As with most (a) Specifications. Each fluid ounce of anthelmintics, drastic cathartics or suspension contains 7.5 grams of piper- other gastrointestinal irritants should azine-carbon disulfide complex. The pi- not be administered in conjunction perazine-carbon disulfide complex con- with this drug. Animals in poor condi- tains equimolar parts of piperazine and tion or heavily parasitized should be carbon disulfide (1 gram contains 530 given one half the recommended dose mgs of piperazine and 470 mgs of carbon and treated again in 2 or 3 weeks. Con- disulfide). sult your veterinarian for assistance in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. the diagnosis, treatment, and control (c) Conditions of use in horses and of parasitism. ponies—(1) Amount. Administer 1 fluid [45 FR 52782, Aug. 8, 1980, as amended at 78 ounce per 100 pounds of body weight by FR 28826, May 20, 2014]

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§ 520.1802c Piperazine-carbon disul- § 520.1804 Piperazine phosphate cap- fide complex with phenothiazine sules. suspension. (a) Specifications. Each capsule con- (a) Specifications. Each fluid ounce tains 120, 300, or 600 milligrams of pi- contains 5 grams of piperazine-carbon perazine phosphate monohydrate. disulfide complex and 0.83 gram of (b) Sponsor. See No. 054771 in phenothiazine. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use—(1) Amount. 60 § 510.600(c) of this chapter. milligrams of piperazine phosphate (c) Conditions of use in horses and monohydrate per pound of body weight. ponies—(1) Amount. Administer 1 fluid (2) Indications for use—(i) Dogs. It is ounce per 100 pounds of body weight by used for the removal of large stomach tube or dose syringe after roundworms (ascarids) Toxocara canis withholding feed overnight or for 8 to and Toxascaris leonina. 10 hours. (ii) Cats. It is used for the removal of (2) Indications for use. For removing large roundworms (ascarids) Toxocara ascarids (large roundworms, Parascaris mystax and Toxacaris leonina. equorum), bots (Gastrophilus spp.), small (3) Limitations. Administer in ani- strongyles, and large strongyles mal’s food or milk. For animals up to (Strongylus spp.). 1 year of age administer every 2 or 3 (3) Limitations. Do not use in horses months; for animals over 1 year old, intended for human consumption. Fed- administer periodically as necessary. eral law restricts this drug to use by or Consult your veterinarian for assist- on the order of a licensed veterinarian. ance in the diagnosis, treatment, and control of parasitism. [45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] [43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 FR 20158, Apr. 3, 1981; § 520.1803 Piperazine citrate capsules. 69 FR 31878, June 8, 2004; 78 FR 28826, May 20, 2014] (a) Specifications. Each capsule con- tains piperazine citrate equivalent to § 520.1805 Piperazine phosphate with 140 milligrams of piperazine base. thenium closylate tablets. (b) Sponsor. See No. 021091 in (a) Specifications. Each scored tablet § 510.600(c) of this chapter. contains the equivalent of 250 milli- (c) Conditions of use in dogs and cats— grams piperazine hexahydrate (as pi- (1) Amount. The contents of 1 capsule perazine phosphate) and 125 milligrams should be mixed with the food of the thenium (as thenium closylate) or 500 animal for each 5 pounds, or fraction milligrams piperazine hexahydrate (as thereof of body weight, except dogs piperazine phosphate) and 250 milli- weighing over 25 pounds should be grams thenium (as thenium closylate). given the contents of 6 capsules. The (b) Sponsor. See No. 000061 in drug should be mixed in 1/2 of the reg- § 510.600(c) of this chapter. ular feeding and when the animal has (c) Conditions of use—(1) Amount. Ad- finished eating the dosed food, the re- minister orally to dogs as follows: mainder of the food may be given. Dogs and cats may be wormed at 6 to 8 NUMBER OF TABLETS AT EACH OF THE TWO weeks of age. The first treatment DOSES should be repeated 10 days later. Rein- Animal weight (lb) 375 mg 750 mg fection may occur. Repeat treatment if indicated. 2 but less than 5 ...... 1⁄2 ...... (2) Indications for use. For the re- 5 but less than 10 ...... 1 1⁄2 10 or heavier ...... 2 1 moval of large roundworms (Toxocara canis and Toxascaris leonina). (2) Indications for use. For removal of (3) Limitations. Severely debilitated immature (fourth stage larvae) and animals should not be treated except adult hookworms (Ancylostoma on the advice of a veterinarian. caninum, A. braziliense, and Uncinaria [40 FR 13838, Mar. 27, 1975, as amended at 54 stenocephala) and ascarids (Toxocara FR 38515, Sept. 19, 1989; 78 FR 28826, May 20, canis) from weaned pups and adult 2014] dogs.

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(3) Limitations. Federal law restricts (2) Turkeys—(i) Amount. 100 milli- this drug to use by or on the order of a grams per bird up to 12 weeks and 200 licensed veterinarian. milligrams per bird over 12 weeks. [43 FR 32747, July 28, 1978, as amended at 47 (ii) Indications for use. For removal of FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, large roundworm (Ascaridia spp.). 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, (iii) Limitations. For use in drinking May 20, 2014] water or feed. Use as sole source of drinking water. Prepare fresh solution § 520.1806 Piperazine suspension. daily. Use as 1-day single treatment. (a) Specifications. Each milliliter of Withdraw 14 days prior to slaughter. suspension contains piperazine Consult your veterinarian for assist- monohydrochloride equivalent to 33.5 ance in the diagnosis, treatment, and milligrams (mg) piperazine base. control of parasitism. (b) Sponsor. See No. 017135 in (3) Swine—(i) Amount. 50 milligrams § 510.600(c) of this chapter. per pound of body weight. (c) Special considerations. See (ii) Indications for use. For removal of § 500.25(c) of this chapter. large roundworm (Ascaris suum) and (d) Conditions of use in dogs—(1) Indi- nodular worms (Oesophagostomum spp.). cations for use. For the removal of roundworms (Toxocara canisand (iii) Limitations. For use in drinking Toxascaris leonina). water or feed. Use as sole source of (2) Dosage. Administer 20 to 30 mg pi- drinking water. Prepare fresh solution perazine base per pound body weight as daily. Use as 1-day single treatment. a single dose. Withdraw 21 days prior to slaughter. (3) Limitations. Administer by mixing Consult your veterinarian for assist- into the animal’s ration to be con- ance in the diagnosis, treatment, and sumed at one feeding. For animals in control of parasitism. heavily contaminated areas, reworm at [64 FR 23018, Apr. 29, 1999, as amended at 79 monthly intervals. Not for use in FR 28827, May 20, 2014] unweaned pups or animals less than 3 weeks of age. § 520.1840 Poloxalene. [70 FR 17319, Apr. 6, 2005] (a) Specifications. Polyoxypropylene- polyoxyethylene glycol nonionic block § 520.1807 Piperazine. polymer. (a) Specifications. A soluble powder or (b) Sponsors. See sponsors in liquid containing piperazine § 510.600(c) of this chapter for use as in dihydrochloride or dipiperazine sulfate, paragraph (d) of this section. equivalent to 17, 34, or 230 grams of pi- (1) No. 054771 for use as in paragraphs perazine per pound or 100 milliliters. (d)(1) and (d)(3) of this section. (b) Sponsor. See No. 015565 in (2) No. 051311 for use as in paragraph § 510.600(c) of this chapter. (d)(4) of this section. (c) See § 556.513 of Related tolerances. (3) No. 067949 for use as in paragraph this chapter. (d)(2) of this section. (d) Conditions of use—(1) Chickens—(i) Amount. 50 milligrams per bird under 6 (4) No. 066104 for use as in paragraph weeks, 100 milligrams per bird over 6 (d)(3) of this section. weeks. (c) [Reserved] (ii) Indications for use. For removal of (d) Conditions of use. (1) For treat- large roundworm (Ascaridia spp.). ment of legume (alfalfa, clover) bloat (iii) Limitations. For use in drinking in cattle. Administer as a drench at the water or feed. Use as sole source of rate of 25 grams for animals up to 500 drinking water. Prepare fresh solution pounds and 50 grams for animals over daily. Use as 1-day single treatment. 500 pounds of body weight. Withdraw 14 days prior to slaughter. (2) For control of legume (alfalfa, clo- Do not use for chickens producing eggs ver) bloat in cattle. Administer, in mo- for human consumption. Consult your lasses block containing 6.6 percent veterinarian for assistance in the diag- poloxalene, at the rate of 0.8 oz. of nosis, treatment, and control of para- block (1.5 grams poloxalene) per 100 lbs. sitism. of body weight per day.

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(3) For prevention of legume (alfalfa, out adequate forage/roughage consump- clover) and wheat pasture bloat in cat- tion. tle. A 53-percent poloxalene top dress- [50 FR 48189, Nov. 22, 1985, as amended at 56 ing on individual rations of ground FR 9841, Mar. 8, 1991; 69 FR 62811, Oct. 28, feed. Dosage is 1 gram of poloxalene 2004] per 100 pounds of body weight daily. If bloating conditions are severe, the dose § 520.1855 Ponazuril. is doubled. Treatment should be start- (a) Specifications. Each gram of paste ed 2 to 3 days before exposure to bloat- contains 150 milligrams (mg) ponazuril. producing conditions. Repeat use of the (b) Sponsor. See No. 050604 in drug if animals are exposed to bloat- § 510.600(c) of this chapter. producing conditions for more than 12 (c) Conditions of use in horses—(1) hours after the last treatment. Do not Amount. Administer orally 15 mg per exceed the double dose in any 24-hour kilogram (kg) (6.81 mg per pound (lb)) period. body weight as the first dose, followed (4) For control of legume (alfalfa, clo- by 5 mg/kg (2.27 mg/lb) body weight ver) and wheat pasture bloat in cattle. once daily for a period of 27 additional Administer in molasses block con- days. (2) For the treat- taining 6.6 percent poloxalene, at the Indications for use. ment of equine protozoal rate of 0.8 ounce of block (1.5 grams of myeloencephalitis caused by Sarcocystis poloxalene) per 100 pounds of body neurona. weight per day. Provide access to (3) Limitations. Do not use in horses blocks at least 7 days before exposure intended for human consumption. Fed- to bloat-producing conditions. eral law restricts this drug to use by or [40 FR 13838, Mar. 27, 1975, as amended at 40 on the order of a licensed veterinarian. FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, [66 FR 43774, Aug. 21, 2001, as amended at 79 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. FR 28827, May 20, 2014; 80 FR 34278, June 16, 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, 2015; 80 FR 53459, Sept. 4, 2015] May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; § 520.1860 Pradofloxacin. 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, 2014] (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) § 520.1846 Polyoxyethylene (23) lauryl pradofloxacin. ether blocks. (b) Sponsor. See No. 000859 in § 510.600(c) of this chapter. (a) Specifications. Each molasses- (c) Conditions of use in cats—(1) based block contains 2.2 percent Amount. Administer 3.4 mg/lb (7.5 mg/ polyoxyethylene (23) lauryl ether. kg) body weight once daily for 7 con- (b) Sponsor. See No. 067949 in secutive days. § 510.600(c) of this chapter. (2) Indications for use. For the treat- (c) Conditions of use—(1) Amount. 2 ment of skin infections (wounds and grams of polyoxyethylene (23) lauryl abscesses) in cats caused by susceptible ether per 100 kilograms of body weight strains of Pasteurella multocida, Strepto- per day (1 pound of block per 500 kilo- coccus canis, Staphylococcus aureus, gram (1,100 pound) animal per day). Staphylococcus felis, and Staphylococcus (2) Indications for use. For reduction pseudintermedius. of the incidence of bloat (alfalfa and (3) Limitations. Federal law prohibits clover) in pastured cattle. the extralabel use of this drug in food- (3) Limitations. Administer free- producing animals. Federal law re- choice to beef cattle and nonlactating stricts this drug to use by or on the dairy cattle only. Initially, provide one order of a licensed veterinarian. block per five head of cattle. Start [77 FR 76863, Dec. 31, 2012, as amended at 79 treatment 10 to 14 days before exposure FR 28827, May 20, 2014] to bloat-producing pastures. Do not allow cattle access to other sources of § 520.1870 Praziquantel tablets. salt while being fed this product. Do (a) Specifications. Each tablet con- not feed this product to animals with- tains:

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(1) 34 milligrams (mg) praziquantel. § 520.1871 Praziquantel and pyrantel. (2) 11.5 or 23 mg praziquantel. (a) Specifications. (1) Each tablet con- (b) Sponsor. See No. 069043 in tains 13.6 milligrams (mg) praziquantel § 510.600(c) of this chapter for use of the and 54.3 mg pyrantel base (as pyrantel product described in paragraph (a)(1) of pamoate), 18.2 mg praziquantel and 72.6 this section as in paragraph (c)(1) of mg pyrantel base (as pyrantel this section; and for use of the product pamoate), or 27.2 mg praziquantel and described in paragraph (a)(2) of this 108.6 mg pyrantel base (as pyrantel section as in paragraph (c)(2) of this pamoate). section. (2) Each chewable tablet contains 30 (c) Conditions of use—(1) Dogs—(i) mg praziquantel and 30 mg pyrantel Amount. 5 pounds (lb) and under, 1⁄2 tab- pamoate or 114 mg praziquantel and 114 let (17 mg); 6 to 10 lb, 1 tablet (34 mg); mg pyrantel pamoate. 11 to 15 lb, 11⁄2 tablets (51 mg); 16 to 30 (b) Sponsors. See sponsors in lb, 2 tablets (68 mg); 31 to 45 lb, 3 tab- § 510.600(c) for use as in paragraph (d) of lets (102 mg); 46 to 60 lb, 4 tablets (136 this chapter. mg); over 60 lb, 5 tablets maximum (170 (1) See No. 000859 for use of tablets mg). Administer directly by mouth or described in paragraph (a)(1) of this crumbled and in feed. section for use as in paragraph (d)(1) of (ii) Indications for use—(A) For re- this section. moval of canine cestodes Dipylidium (2) See No. 051311 for use of tablets caninum and Taenia pisiformis. described in paragraph (a)(2) of this (B) For removal of the canine cestode section for use as in paragraph (d)(2) of Echinococcus granulosus, and for re- this section. moval and control of the canine (c) Special considerations. See § 500.25 cestode Echinococcus multilocularis. of this chapter. (iii) Limitations—(A) If labeled only (d) Conditions of use—(1) Cats—(i) Dos- for use as in paragraph (c)(1)(ii)(A) of age. Administer a minimum dose of 2.27 this section: Not intended for use in mg praziquantel and 9.2 mg pyrantel puppies less than 4 weeks of age. Con- pamoate per pound of body weight ac- sult your veterinarian before admin- cording to the dosing tables on label- istering tablets to weak or debilitated ing. May be given directly by mouth or animals and for assistance in the diag- in a small amount of food. Do not with- nosis, treatment, and control of para- hold food prior to or after treatment. If sitism. reinfection occurs, treatment may be (B) If labeled for use as in paragraph repeated. (c)(1)(ii)(B) of this section: Federal law (ii) Indications for use. For removal of restricts this drug to use by or on the tapeworms (Dipylidium caninum and order of a licensed veterinarian. Taenia taeniaeformis), hookworms (2) Cats—(i) Indications for use. For re- (Ancylostoma tubaeforme), and large moval of feline cestodes Dipylidium roundworms (Toxocara cati) in cats and caninum and Taenia taeniaeformis. kittens. (ii) Dosage. Cats 4 pounds and under, (iii) Limitations. Not for use in kit- 11.5 mg; 5 to 11 pounds, 23 mg; over 11 tens less than 2 months of age or pounds, 34.5 mg. weighing less than 2.0 pounds. Consult (iii) Limitations. Administer directly your veterinarian before giving to sick by mouth or crumbled and in feed. Not or pregnant animals. intended for use in kittens less than 6 (2) Dogs—(i) Amount. Administer a weeks of age. For OTC use: Consult minimum dose of 5 mg praziquantel your veterinarian before administering and 5 mg pyrantel pamoate per kilo- tablets to weak or debilitated animals, gram body weight (2.27 mg praziquantel and for assistance in the diagnosis, and 2.27 mg pyrantel pamoate per treatment, and control of parasitism. pound body weight) according to the dosing tables on labeling. [46 FR 60570, Dec. 11, 1981, as amended at 47 (ii) Indications for use. For the treat- FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, ment and control of roundworms Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR (Toxocara canis and Toxascaris leonina), 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; hookworms (Ancylostoma caninum, 81 FR 17607, Mar. 30, 2016] Ancylostoma braziliense, and Uncinaria

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stenocephala), and tapeworms § 520.1880 Prednisolone. (Dipylidium caninum and Taenia (a) Specifications. Each tablet con- pisiformis) in dogs and puppies. tains 5 or 20 milligrams prednisolone. [58 FR 58652, Nov. 3, 1993, as amended at 72 (b) Sponsor. See No. 061690 in FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, § 510.600(c)(2) of this chapter. 2010] (c) Conditions of use in dogs—(1) Amount. Administer 2.5 milligrams per § 520.1872 Praziquantel, pyrantel 4.5 kilograms (10 pounds) body weight pamoate, and febantel tablets. per day. Administer total daily dose (a) Specifications. Each tablet or orally in equally divided doses 6 to 10 chewable tablet contains either: hours apart until response is noted or 7 (1) Tablet No. 1: 22.7 milligrams days have elapsed. When response is at- praziquantel, 22.7 milligrams pyrantel tained, dosage should be gradually re- base, and 113.4 milligrams febantel; or duced until maintenance level is (2) Tablet No. 2: 68 milligrams achieved. praziquantel, 68 milligrams pyrantel (2) Indications for use. For use as an base, and 340.2 milligrams febantel. anti-inflammatory agent. (3) Tablet No. 3: 136 milligrams (mg) (3) Limitations. Federal law restricts praziquantel, 136 mg pyrantel base, and this drug to use by or on the order of a 680.4 mg febantel. licensed veterinarian. (b) Sponsor. See 000859 in § 510.600(c) of this chapter. [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 (c) Conditions of use—(1) Dogs—(i) FR 28827, May 20, 2014] Amount. Administer as a single dose di- rectly by mouth or in a small amount § 520.1900 Primidone. of food as follows: (a) Specifications. Each tablet con- Weight of animal Number of tablets per dose tains 50 or 250 milligrams of primidone. (b) Sponsors. See sponsor numbers in Tablet Tablet Tablet Kilograms Pounds no. 1 no. 2 no. 3 § 510.600(c) of this chapter. (1) No. 054628 for use of 250 milligram 0.9 to 1.8 ...... 2 to 4 ...... 1/2. tablets. 2.3 to 3.2 ...... 5 to 7 ...... 1. 3.6 to 5.4 ...... 8 to 12 ..... 1 1/2. (2) No. 054771 for use of 50 and 250 mil- 5.9 to 8.2 ...... 13 to 18 ... 2. ligram tablets. 8.6 to 11.4 .... 19 to 25 ... 2 1/2. (c) Conditions of use in dogs—(1) 11.8 to 13.6 .. 26 to 30 ...... 1. 14.1 to 20.0 .. 31 to 44 ...... 1 1/2. Amount. Twenty-five milligrams of 20.4 to 27.2 .. 45 to 60 ...... 2 ...... 1 primidone per pound of body weight (55 27.7 to 40.9 .. 61 to 90 ...... 1 1/2 milligrams per kilogram of body 41.3 to 54.5 .. 91 to 120 ...... 2 weight) daily. (2) Indications for use. For the control (ii) Indications for use. For the re- of convulsions associated with idio- moval of tapeworms (Dipylidium pathic epilepsy, epileptiform convul- caninum, Taenia pisiformis, Echinococcus sions, viral encephalitis, distemper, granulosus); hookworms (Ancylostoma and hardpad disease that occurs as a caninum, Uncinaria stenocephala); clinically recognizable lesion in certain ascarids (Toxocara canis, Toxascaris entities in dogs. leonina); and whipworms (Trichuris (3) Limitations. Federal law restricts vulpis) and for the removal and control this drug to use by or on the order of a of tapeworm Echinococcus multilocularis licensed veterinarian. in dogs. (iii) Limitations. Do not use in preg- [42 FR 61594, Dec. 6, 1977, as amended at 43 nant animals. Do not use in dogs FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, weighing less than 0.9 kilogram (2 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR pounds) or puppies less than 3 weeks of 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; age. Federal law restricts this drug to 79 FR 28827, May 20, 2014] use by or on the order of a licensed vet- erinarian. § 520.1920 Prochlorperazine and isopropamide. [59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, (a) Specifications. Each capsules con- 2003; 71 FR 6677, Feb. 9, 2006] tains either:

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(1) 3.33 milligrams of Number of cap- prochlorperazine (as the dimaleate) sules per dose Animal weight (pounds) and 1.67 milligrams of isopropamide (as Capsule Capsule the iodide); or No. 1 No. 3 (2) 10 milligrams of prochlorperazine Over 60 ...... 2 (as the dimaleate) and 5 milligrams of isopropamide (as the iodide). (2) Indications for use. For the treat- (b) Sponsor. See No. 054771 in ment infectious bacterial § 510.600(c) of this chapter. gastroenteritis associated with emo- (c) Conditions of use in dogs—(1) tional stress. Amount. (i) Capsules described in para- (3) Limitations. Federal law restricts graph (a)(1) of this section are adminis- this drug to use by or on the order of a tered orally to dogs weighing from 4 to licensed veterinarian. 15 pounds at the rate of 1 capsule twice daily. These capsules are administered [49 FR 14103, Apr. 10, 1984, as amended at 56 orally to dogs weighing from 16 to 30 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, pounds at the rate of 1 or 2 capsules 1995; 79 FR 28827, May 20, 2014] twice daily. For dogs weighing less than 4 pounds, administer orally an ap- § 520.1962 Promazine. propriate fraction of the contents of (a) Specifications. Conforms to N.F. one of these capsules. XII for promazine hydrochloride. (ii) Capsules described in paragraph (b) Sponsor. See No. 054771 in (a)(2) of this section are given to dogs § 510.600(c) of this chapter. weighing 30 pounds and over at the rate (c) Conditions of use in horses—(1) of 1 capsule twice daily. (2) Indications for use. For the treat- Amount. Administer 0.45 to 0.9 milli- ment of gastrointestinal disturbances grams per pound of body weight mixed associated with emotional stress. with an amount of feed that will be (3) Limitations. Federal law restricts readily consumed. this drug to use by or on the order of a (2) Indications for use. For quieting licensed veterinarian. excitable, unruly, or intractable horses. [79 FR 28827, May 20, 2014] (3) Limitations. Do not use in horses § 520.1921 Prochlorperazine, intended for human consumption. Fed- isopropamide, and neomycin. eral law restricts this drug to use by or (a) Specifications. Each capsule con- on the order of a licensed veterinarian. tains either: [79 FR 28827, May 20, 2014] (1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), § 520.2002 Propiopromazine. 1.67 milligrams of isopropamide (as the (a) Specifications. Each chewable tab- iodide), and 25 milligrams of neomycin base (as the sulfate); or let contains 10 or 20 milligrams of (2) Capsule No. 3: 10 milligrams of propiopromazine hydrochloride. prochlorperazine (as the dimaleate), 5 (b) Sponsor. See No. 054771 in milligrams of isopropamide (as the io- § 510.600(c) of this chapter. dide), and 75 milligrams of neomycin (c) Conditions of use in dogs—(1) base (as the sulfate). Amount. Administer 0.5 to 2.0 milli- (b) Sponsor. See No. 054771 in grams per pound of body weight once § 510.600(c) of this chapter. or twice daily, depending upon the de- (c) Conditions of use in dogs—(1) gree of tranquilization desired. Amount. Administer capsules orally (2) Indications for use. For oral admin- twice daily to dogs as follows: istration as a tranquilizer. As an aid in handling difficult, excited, and unruly Number of cap- sules per dose dogs, and in controlling excessive ken- Animal weight (pounds) nel barking, car sickness, and severe Capsule Capsule No. 1 No. 3 dermatitis. It is also indicated for use in minor surgery and prior to routine 10 to 20 ...... 1 20 to 30 ...... 2 examinations, laboratory procedures, Over 30 ...... 3 1 and diagnostic procedures.

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(3) Limitations. Federal law restricts (2) Indications for use. For removal this drug to use by or on the order of a and control of large roundworms licensed veterinarian. (ascarids) (Toxocara canis and [79 FR 28827, May 20, 2014] Toxascaris leonina), and hookworms (Ancylostoma caninum and Uncinaria § 520.2041 Pyrantel pamoate chewable stenocephala). tablets. (3) Limitations. Administer orally di- (a) Specifications. Each tablet con- rectly or in a small amount of food. To tains pyrantel pamoate equivalent to prevent reinfection of T. canis in pup- 22.7 or 113.5 milligrams pyrantel base. pies, lactating bitches after whelping, (b) Sponsor. See Nos. 066916, 017135, and adult dogs; treat puppies 2, 3, 4, 6, and 051311 in § 510.600(c) of this chapter. 8, and 10 weeks of age; treat lactating (c) Conditions of use—(1) Amount. Pro- bitches 2 to 3 weeks after whelping; vides at least 2.27 milligrams pyrantel routinely treat adult dogs monthly. Do base per pound body weight for dogs not withhold food prior to or after weighing more than 5 pounds, and at treatment. The presence of these least 4.54 milligrams of pyrantel base parasites should be confirmed by lab- per pound body weight for dogs weigh- oratory fecal examination. A followup ing 5 pounds or less. fecal examination should be conducted (2) Indications for use—(i) In dogs and 2 to 4 weeks after first treatment regi- puppies. For removal of ascarids men to determine the need for re-treat- (Toxocara canis; Toxascaris leonina) and ment. Consult your veterinarian for as- hookworms (Ancylostoma caninum; sistance in the diagnosis, treatment, Uncinaria stenocephala). and control of parasitism. (ii) In puppies and adult dogs and in [43 FR 52700, Nov. 14, 1978, as amended at 49 lactating bitches after whelping. To FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, prevent reinfection of Toxocara canis. 1992; 58 FR 44611, Aug. 24, 1993] (3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- § 520.2043 Pyrantel pamoate suspen- minister to lactating bitches 2 to 3 sion. weeks after whelping. Retreatment of (a) Specifications. (1) Each milliliter adult dogs may be necessary at month- (mL) contains pyrantel pamoate equiv- ly intervals as determined by labora- alent to 50 milligrams (mg) pyrantel tory fecal examinations. Consult your base. veterinarian for assistance in the diag- (2) Each mL contains pyrantel nosis, treatment, and control of para- pamoate equivalent to 2.27 or 4.54 mg sitism. pyrantel base. [52 FR 37937, Oct. 13, 1987, as amended at 57 (3) Each mL contains pyrantel FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, pamoate equivalent to 4.54 mg pyrantel 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May base. 2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169, Mar. 1, 2017] (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in § 520.2042 Pyrantel pamoate tablets. paragraph (d) of this section. (a) Specifications. Each tablet con- (1) Nos. 054771, 058829, and 069043 for tains pyrantel pamoate equivalent to use of the product described in para- 22.7, 45.4, or 113.5 milligrams of graph (a)(1) as in paragraph (d)(1) of pyrantel base. this section. (b) Sponsor. See No. 017135 in (2) Nos. 000859, 054771, and 058829 for § 510.600(c) of this chapter. use of the products described in para- (c) Conditions of use. It is used for graph (a)(2) as in paragraph (d)(2) of dogs as follows: this section. (1) Amount. For dogs weighing over 5 (3) No. 023851 for use of the product pounds, use at least 2.27 milligrams of described in paragraph (a)(3) as in para- pyrantel base per pound of body graph (d)(2) of this section. weight; for dogs weighing 5 pounds or (c) Special considerations. See § 500.25 less, use at least 4.54 milligrams of of this chapter. pyrantel base per pound of body (d) Conditions of use—(1) Horses and weight. ponies. It is used as follows:

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(i) Amount. 3 mg per pound (/lb) body (b) Sponsors. See sponsors in weight as a single dose mixed with the § 510.600(c) of this chapter. usual grain ration, or by stomach tube (1) No. 054771 for use of product de- or dose syringe. scribed in paragraph (a)(1) of this sec- (ii) Indications for use. For the re- tion as in paragraph (d)(1)(i) and (d)(2) moval and control of mature infections of this section. of large strongyles (Strongylus vulgaris, (2) No. 017135 for use of product de- S. edentatus, S. equinus); pinworms scribed in paragraph (a)(2) of this sec- (Oxyuris equi); large roundworms tion as in paragraph (d) of this section. (Parascaris equorum); and small (3) No. 061623 for use of product de- strongyles. scribed in paragraph (a)(3) of this sec- (iii) Limitations. Do not use in horses tion as in paragraph (d)(1)(i) and (d)(2) intended for human consumption. of this section. When the drug is for administration by (c) Special considerations. See § 500.25 stomach tube, it shall be labeled: of this chapter. ‘‘Federal law restricts this drug to use (d) Conditions of use. It is used in by or on the order of a licensed veteri- horses and ponies as follows: narian.’’ (1) Amounts and indications for use—(i) (2) Dogs. It is used as follows: 3 mg per pound (/lb) body weight as sin- (i) Dogs and puppies—(A) Amount. 2.27 gle oral dose for removal and control of mg/lb body weight as a single dose in infections from the following mature the animal’s feed bowl by itself or parasites: large strongyles (Strongylus mixed in a small quantity of food. vulgaris, S. edentatus, S. equinus); small (B) Indications for use. For the re- strongyles; pinworms (Oxyuris equi); moval of large roundworms (Toxocara and large roundworms (Parascaris canis and Toxascaris leonina) and equorum). hookworms (Ancylostoma caninum and (ii) 6 mg/lb body weight as single oral Uncinaria stenocephala). dose for the removal and control of ma- (C) Limitations. Additional treatment ture infections of tapeworms may be required and should be con- (Anoplocephala perfoliata). firmed by fecal examination within 2 (2) Limitations. Do not use in horses to 4 weeks. intended for human consumption. (ii) Dogs, puppies, and lactating bitches [70 FR 29447, May 23, 2005, as amended at 76 after whelping—(A) Amount. 2.27 mg/lb FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, body weight. 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, (B) Indications for use. To prevent re- Mar. 30, 2016] infections of T. canis. (C) Limitations. Administer to puppies § 520.2045 Pyrantel tartrate powder. at 2, 3, 4, 6, 8, and 10 weeks of age. Ad- (a) Specifications. Each gram of pow- minister to lactating bitches 2 to 3 der contains 106 milligrams (10.6 per- weeks after whelping. Adult dogs kept cent) or 113 milligrams (11.3 percent) in heavily contaminated quarters may pyrantel tartrate. be treated at monthly intervals. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of 11.3 [67 FR 43248, June 27, 2002, as amended at 68 percent powder as in paragraph (d)(1) FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, and 10.6 percent powder as in paragraph Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR (d)(2) and of this section. 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; (c) Related tolerances. See § 556.560 of 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, this chapter. 2016] (d) Conditions of use—(1) Horses—(i) Amount. Administer as a single dose at § 520.2044 Pyrantel pamoate paste. 0.57 gram of pyrantel tartrate per 100 (a) Specifications—(1) Each milliliter pounds of body weight mixed with the (mL) contains 180 milligrams (mg) usual grain ration. Do not administer pyrantel base (as pyrantel pamoate). by stomach tube or dose syringe. (2) Each mL contains 226 mg pyrantel (ii) Indications for use. For the re- base (as pyrantel pamoate). moval and control of infections from (3) Each mL contains 171 mg pyrantel the following mature parasites: Large base (as pyrantel pamoate). strongyles (Strongylus vulgaris, S.

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edentatus, S. equinus), small strongyles § 520.2075 Robenacoxib. (Trichonema spp., Triodontophorus), (a) Specifications. Each tablet con- pinworms (Oxyuris), and large tains 10, 20, or 40 milligrams (mg) roundworms (Parascaris). robenacoxib for use in dogs, or 6 mg (iii) Limitations. Do not treat severely robenacoxib for use in cats. debilitated animals with this drug. Do (b) Sponsors. See No. 058198 in not use in horses intended for human § 510.600(c) of this chapter. consumption. (c) Conditions of use—(1) Dogs—(i) (2) Swine—(i) Amount. Add to feed at Amount. Administer 0.91 mg/lb (2 mg/ 0.4 gram pyrantel tartrate per pound of kg) orally, once daily, for a maximum non-pelleted ration. The ration is ad- of 3 days. ministered as a single treatment as the (ii) Indications for use. For the control sole ration at the rate of 1 pound per 40 of postoperative pain and inflamma- pounds of animal weight for animals up tion associated with soft tissue surgery to 200 pounds. Animals 200 pounds and in dogs weighing at least 5.5 lb (2.5 kg) over are administered 5 pounds of ra- and at least 4 months of age for a max- tion per animal. imum of 3 days. (ii) Indications for use. For the re- (iii) Federal law restricts moval and control of large roundworms Limitations. this drug to use by or on the order of a (Ascaris suum) and nodular worm licensed veterinarian. (Oesophagostomum) infections. (iii) Limitations. Consult veterinarian (2) Cats—(i) Amount. Administer 0.45 before using in severely debilitated mg/lb (1 mg/kg) orally, once daily, for a animals. Do not treat within 24 hours maximum of 3 days. of slaughter. (ii) Indications for use. For the control of postoperative pain and inflamma- [79 FR 28827, May 20, 2014] tion associated with orthopedic sur- gery, ovariohysterectomy, and castra- § 520.2046 Pyrantel tartrate pellets. tion in cats weighing at least 5.5 lb (2.5 (a) Specifications. (1) Each gram of kg) and at least 4 months of age for a pellets contains 12.5 milligrams (mg) maximum of 3 days. (1.25 percent) pyrantel tartrate; or (iii) Limitations. Federal law restricts (2) Each gram of pellets contains 21.1 this drug to use by or on the order of a mg (2.11 percent) pyrantel tartrate. licensed veterinarian. (b) Sponsors. See sponsor numbers in [76 FR 18648, Apr. 5, 2011, as amended at 79 § 510.600(c) of this chapter: FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, (1) No. 054771 for use of products de- 2016] scribed in paragraph (a) as in para- graph (c) of this section. § 520.2086 Sarolaner. (2) No. 061623 for use of product de- (a) Specifications. Each chewable tab- scribed in paragraph (a)(1) as in para- let contains 5, 10, 20, 40, 80, or 120 milli- graph (c) of this section. grams (mg) sarolaner. (c) Conditions of use in horses—(1) (b) Sponsor. See No. 054771 in Amount. Administer as a single dose at § 510.600(c) of this chapter. 12.5 mg per 2.2 pounds of body weight (c) Conditions of use in dogs—(1) mixed with the usual grain ration. Amount. Administer orally once a (2) Indications for use. For the re- month at the recommended minimum moval and control of infections from dosage of 0.9 mg/lb (2 mg/kg). the following mature parasites: Large (2) Indications for use. Kills adult strongyles ( Strongylus vulgaris, S. fleas, and for the treatment and pre- ), small strongyles edentatus, S. equinus vention of flea infestations (Trichonema spp., Triodontophorus), (Ctenocephalides felis), and the treat- pinworms ( ), and large Oxyuris ment and control of tick infestations roundworms (Parascaris). [Amblyomma americanum (lone star (3) Limitations. Do not treat severely tick), Amblyomma maculatum (Gulf debilitated animals with this drug. Do Coast tick), Dermacentor variabilis not use in horses intended for human (American dog tick), Ixodes scapularis consumption. (black-legged tick), and Rhipicephalus [79 FR 28828, May 20, 2014] sanguineus (brown dog tick)] for 1

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month in dogs 6 months of age or older intervals until a satisfactory response and weighing 2.8 pounds or greater. is observed. Maintenance dosage is 1 (3) Limitations. Federal law restricts capsule per 10 pounds of body weight this drug to use by or on the order of a every 3 to 7 days, or longer, as re- licensed veterinarian. quired. (2) Indications for use. As an aid in al- [81 FR 22523, Apr. 18, 2016, as amended at 82 FR 12169, Mar. 1, 2017] leviating and controlling inflamma- tion, pain, and lameness associated § 520.2098 Selegiline. with certain arthropathies. (a) Specifications. Each tablet con- (3) Limitations. Federal law restricts tains 2, 5, 10, 15, or 30 milligrams (mg) this drug to use by or on the order of a selegiline hydrochloride. licensed veterinarian. (b) Sponsor. See No. 054771 in [79 FR 28828, May 20, 2014] § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) § 520.2123 Spectinomycin oral dosage Amounts and indications for use. (i) Ad- forms. minister 1 mg per kilogram (0.45 mg per pound) of body weight once daily § 520.2123a Spectinomycin tablets. for control of clinical signs associated (a) Specifications. Each tablet con- with uncomplicated pituitary-depend- tains spectinomycin dihydrochloride ent hyperadrenocorticism in dogs. equivalent to 100 milligrams (mg) (ii) Administer 0.5 to 1.0 mg per kilo- spectinomycin. gram of body weight once daily for the (b) Sponsors. See Nos. 054771 and control of clinical signs associated 061623 in § 510.600(c) of this chapter. with canine cognitive dysfunction syn- (c) Conditions of use in dogs—(1) drome. Amount. Administer orally to provide (2) Limitations. Federal law restricts 10 mg per pound (lb) of body weight this drug to use by or on the order of a twice daily. Dosage may be continued licensed veterinarian. for 4 consecutive days. (2) Indications for use. For the treat- [79 FR 28828, May 20, 2014] ment of infectious diarrhea and § 520.2100 Selenium and vitamin E. gastroenteritis caused by organisms susceptible to spectinomycin. (a) Each capsule con- Specifications. (3) Limitations. Federal law restricts tains: this drug to use by or on the order of a (1) 2.19 milligrams (mg) sodium sele- licensed veterinarian. nite (equivalent to 1 mg selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha [73 FR 6607, Feb. 5, 2008, as amended at 79 FR tocopheryl acid succinate; or 28828, May 20, 2014] (2) 0.548 mg sodium selenite (equiva- lent to 0.25 mg selenium) and 14 mg (17 § 520.2123b Spectinomycin powder. I.U.) vitamin E as d-alpha tocopheryl (a) Specifications. Each gram (g) of acid succinate. powder contains spectinomycin (b) Sponsor. See No. 000061 in dihydrochloride pentahydrate equiva- § 510.600(c) of this chapter. lent to 0.5 g spectinomycin. (c) Conditions of use in dogs—(1) (b) Sponsor. See No. 061623 in Amount. (i) Dogs over 20 pounds: Ad- § 510.600(c) of this chapter. minister 1 capsule described in para- (c) Related tolerances. See § 556.600 of graph (a)(1) per 20 pounds of body this chapter. weight to a maximum of 5 capsules. Re- (d) Conditions of use in chickens. It is peat at 3 day intervals until a satisfac- administered in the drinking water of tory therapeutic response is observed. growing chickens as follows: Maintenance dosage is 1 capsule per 40 (1) Indications for use and amounts—(i) pounds of body weight every 3 to 7 As an aid in controlling infectious syn- days, or longer, as required. ovitis due to Mycoplasma synoviae in (ii) Dogs under 20 pounds: Administer broiler chickens, administer 1 g per 1 capsule described in paragraph (a)(2) gallon of water as the only source of per 5 pounds of body weight with a drinking water for the first 3 to 5 days minimum of 1 capsule. Repeat at 3-day of life.

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(ii) As an aid in the prevention or felis) for 1 month on dogs and puppies control of losses due to CRD associated 14 weeks of age and older and 3.3 with M. gallisepticum (PPLO) in grow- pounds of body weight or greater. ing chickens, administer 2 g per gallon (2) Cats—(i) Amount. Administer tab- of water as the only source of drinking lets once a month at a minimum dos- water for the first 3 days of life and for age of 22.5 mg per pound (50 mg per 1 day following each vaccination. kilogram) of body weight. (2) Limitations. Do not administer to (ii) Indications for use. To kill fleas laying chickens. Do not administer and for the prevention and treatment within 5 days of slaughter. Federal law of flea infestations (C. felis) for 1 month restricts this drug to use by or on the on cats and kittens 14 weeks of age and order of a licensed veterinarian. older and 2 pounds of body weight or [73 FR 6607, Feb. 5, 2008, as amended at 81 FR greater. 94990, Dec. 27, 2016] [77 FR 60623, Oct. 4, 2012, as amended at 81 FR § 520.2123c Spectinomycin solution. 48702, July 26, 2016] (a) Specifications. Each milliliter of § 520.2134 Spinosad and milbemycin. solution contains spectinomycin dihydrochloride pentahydrate equiva- (a) Specifications. Each chewable tab- lent to 50 milligrams (mg) let contains 140 milligrams (mg) spectinomycin. spinosad and 2.3 mg milbemycin oxime, (b) Sponsors. See Nos. 016592, 054771, 270 mg spinosad and 4.5 mg milbemycin and 061623 in § 510.600(c) of this chapter. oxime, 560 mg spinosad and 9.3 mg (c) Related tolerances. See § 556.600 of milbemycin oxime, 810 mg spinosad this chapter. and 13.5 mg milbemycin oxime, or 1,620 (d) Conditions of use in swine—(1) mg spinosad and 27 mg milbemycin Amount. Administer 5 mg per pound (lb) oxime. of body weight orally twice daily for 3 (b) Sponsor. See No. 058198 in § 510.600 to 5 days. of this chapter. (2) Indications for use. For the treat- (c) Conditions of use in dogs—(1) ment and control of porcine enteric Amount. Administer once a month at a colibacillosis (scours) caused by E. coli minimum dosage of 13.5 mg/pound (lb) susceptible to spectinomycin in pigs (30 mg/kilogram (kg)) of body weight under 4 weeks of age. spinosad and 0.2 mg/lb (0.5 mg/kg) of (3) Limitations. Do not administer to body weight milbemycin oxime. pigs over 15 lb body weight or over 4 (2) Indications for use. To kill fleas; weeks of age. Do not administer within for the prevention and treatment of 21 days of slaughter. flea infestations (Ctenocephalides felis); [73 FR 6607, Feb. 5, 2008, as amended at 78 FR for the prevention of heartworm dis- 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014; ease (Dirofilaria immitis); and for the 81 FR 22523, Apr. 18, 2016] treatment and control of adult hookworm (Ancylostoma caninum), § 520.2130 Spinosad. adult roundworm (Toxocara canis and (a) Specifications. Each chewable tab- Toxascaris leonina), and adult let contains 90, 140, 270, 560, 810, or 1620 whipworm (Trichuris vulpis) infections milligrams (mg) spinosad. in dogs and puppies 8 weeks of age or (b) Sponsor. See No. 058198 in § 510.600 older and 5 lbs of body weight or great- of this chapter. er. (c) Special considerations. Federal law (3) Limitations. Federal law restricts restricts this drug to use by or on the this drug to use by or on the order of a order of a licensed veterinarian. licensed veterinarian. (d) Conditions of use—(1) Dogs—(i) Amount. Administer tablets once a [76 FR 12563, Mar. 8, 2011, as amended at 81 month at a recommended minimum FR 48702, July 26, 2016] dosage of 13.5 mg per pound (30 mg per kilogram) of body weight. § 520.2150 Stanozolol. (ii) Indications for use. To kill fleas (a) Specifications. Each tablet or and for the prevention and treatment chewable tablet contains 2 milligrams of flea infestations (Ctenocephalides stanozolol.

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(b) Sponsor. No. 054771 in § 510.600(c) of consumption. Federal law restricts this this chapter. drug to use by or on the order of a li- (c) Conditions of use in dogs and cats— censed veterinarian. (1) Amount—(i) Dogs: Administered [57 FR 37327, Aug. 18, 1992, as amended at 58 orally to small breeds, 1⁄2 to 1 tablet FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, twice daily for several weeks; to large 1998. Redesignated and amended at 79 FR breeds, 1 to 2 tablets twice daily for 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014; several weeks. The tablets may be 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, crushed and administered in feed. 2015] (ii) Cats: Administered orally 1⁄2 to 1 tablet twice daily for several weeks. § 520.2170 Sulfabromomethazine. (2) Indications for use. As an anabolic (a) Specifications. Each bolus contains steroid treatment. 15 grams of sulfabromomethazine so- (3) Limitations. Federal law restricts dium. this drug to use by or on the order of a (b) Sponsor. See No. 050604 in licensed veterinarian. § 510.600(c) of this chapter. [79 FR 28828, May 20, 2014] (c) Related tolerance. See § 556.620 of this chapter. § 520.2158 Streptomycin. (d) Conditions of use in cattle—(1) (a) Specifications. Each milliliter of Amount. Administer 90 milligrams per solution contains 250 milligrams (25 pound body weight orally. Repeat in 48 percent) streptomycin sulfate. hours if necessary (b) Sponsor. See No. 016592 in (2) Indications for use. Treatment of § 510.600(c) of this chapter. necrotic pododermatitis (foot rot) and (c) Related tolerances. See § 556.610 of calf diphtheria caused by Fusobacterium this chapter. necrophorum; colibacillosis (scours) (d) Conditions of use. Use in drinking caused by Escherichia coli; bacterial water as follows: pneumonia and bovine respiratory dis- (1) Calves—(i) Amount. 10 to 15 milli- ease complex (shipping fever complex) grams per pound (mg/pound) of body associated with Pasteurella spp.; acute weight (1.0 to 1.5 grams per gallon) for metritis and acute mastitis caused by up to 5 days. Streptococcus spp. (ii) Indications for use. For the treat- (3) Limitations. Milk taken from ani- ment of bacterial enteritis caused by mals within 96 hours (8 milkings) of Escherichia coli and Salmonella spp. sus- latest treatment must not be used for ceptible to streptomycin. food. Do not administer within 18 days (iii) Limitations. Federal law restricts of slaughter. this drug to use by or on the order of a licensed veterinarian. [47 FR 30243, July 13, 1982, as amended at 62 (2) Swine—(i) Amount. 10 to 15 mg/ FR 63270, Nov. 28, 1997; 79 FR 28829, May 20, 2014] pound of body weight (1.0 to 1.5 grams per gallon) for up to 4 days. § 520.2184 Sulfachloropyrazine. (ii) Indications for use. For the treat- ment of bacterial enteritis caused by (a) Specifications. Each gram of pow- Escherichia coli and Salmonella spp. sus- der contains 476 milligrams of sodium ceptible to streptomycin. sulfachloropyrazine monohydrate. (iii) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in this drug to use by or on the order of a § 510.600(c) of this chapter. licensed veterinarian. (c) Related tolerance. See § 556.625 of (3) Chickens—(i) Amount. 10 to 15 mg/ this chapter. pound of body weight (0.6 to 0.9 grams (d) Conditions of use in chickens. It is per gallon) for up to 5 days. used in the drinking water of broilers, (ii) Indications for use. For the treat- breeder flocks, and replacement chick- ment of nonspecific infectious enteritis ens as follows: caused by organisms susceptible to (1) Amount. Administer in drinking streptomycin. water as 0.03 percent solution for 3 (iii) Limitations. Withdraw 4 days be- days. fore slaughter. Do not administer to (2) Indications for use. For the treat- chickens producing eggs for human ment of coccidiosis.

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(3) Limitations. Withdraw 4 days prior body weight daily, in two or three di- to slaughter. Do not use in chickens vided doses. producing eggs for human consump- (ii) Indications for use. As an aid in tion. Federal law restricts this drug to the treatment of infectious use by or on the order of a licensed vet- tracheobronchitis and infections erinarian. caused by E. coli, and in the treatment [79 FR 28829, May 20, 2014, as amended at 81 of infections caused by other Gram- FR 94990, Dec. 27, 2016] positive and Gram-negative organisms that are susceptible to sulfonamide § 520.2200 Sulfachlorpyridazine. therapy. (a) Specifications. (1) Sodium (iii) Limitations. Federal law restricts sulfachlorpyridazine powder. this drug to use by or on the order of a (2) Each bolus contains 2 grams licensed veterinarian. sulfachlorpyridazine. [75 FR 10166, Mar. 5, 2010, as amended at 79 (3) Each tablet contains 250 milli- FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, grams (mg) sulfachlorpyridazine. 2016; 81 FR 94990, Dec. 27, 2016] (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. § 520.2215 Sulfadiazine/pyrimethamine (c) Related tolerances. See § 556.630 of suspension. this chapter. (a) Specifications. Each milliliter (d) Conditions of use. It is used as fol- (mL) of suspension contains 250 milli- lows: grams (mg) sulfadiazine (as the sodium (1) Calves—(i) Amount. Administer 30 salt) and 12.5 mg pyrimethamine. to 45 mg sulfachlorpyridazine powder (b) Sponsor. See No. 055246 in per pound (/lb) of body weight per day § 510.600(c) of this chapter. in milk or milk replacer, or in a bolus, (c) Conditions of use in horses—(1) in divided doses twice daily for 1 to 5 Amount. Administer orally 20 mg sulfa- days. diazine per kilogram (kg) body weight (ii) Indications for use. For the treat- and 1 mg/kg pyrimethamine daily. ment of diarrhea caused or complicated (2) Indications for use. For the treat- by Escherichia coli (colibacillosis). ment of equine protozoal (iii) Limitations. Treated ruminating myeloencephalitis (EPM) caused by calves must not be slaughtered for food Sarcocystis neurona. during treatment or for 7 days after (3) Limitations. Do not use in horses the last treatment. A withdrawal pe- intended for human consumption. Fed- riod has not been established for this eral law restricts this drug to use by or product in preruminating calves. Do on the order of a licensed veterinarian. not use in calves to be processed for [69 FR 70054, Dec. 2, 2004, as amended at 73 veal. Federal law restricts this drug to FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, use by or on the order of a licensed vet- 2010] erinarian. (2) Swine—(i) Amount. Administer 20 § 520.2218 Sulfamerazine, to 35 mg/lb body weight per day, in di- sulfamethazine, and vided doses twice daily for 1 to 5 days: sulfaquinoxaline powder. (A) In drinking water or (a) Specifications. Each 195-gram (g) (B) For individual treatment, in an packet of powder contains 78 g sulfa- oral suspension containing 50 mg per merazine, 78 g sulfamethazine, and 39 g milliliter. sulfaquinoxaline. (ii) Indications for use. For the treat- (b) Sponsor. See No. 016592 in ment of diarrhea caused or complicated § 510.600(c) of this chapter. by E. coli (colibacillosis). (c) Related tolerances. See §§ 556.670 (iii) Limitations. Treated swine must and 556.685 of this chapter. not be slaughtered for food during (d) Conditions of use—(1) Chickens—(i) treatment or for 4 days after the last Amounts and indications for use—(A) As treatment. Federal law restricts this an aid in the control of coccidiosis drug to use by or on the order of a li- caused by Eimeria tenella and E. necatrix censed veterinarian. susceptible to sulfamerazine, (3) Dogs—(i) Amount. Administer tab- sulfamethazine, and sulfaquinoxaline: lets orally at 500 mg per 10 to 15 lb of Provide medicated water (0.04 percent

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solution) for 2 to 3 days, then plain (2) Each 107 grams of powder contains water for 3 days, then medicated water the equivalent of 94.6 grams (0.025 percent solution) for 2 days. If sulfadimethoxine as sulfadimethoxine bloody droppings appear, repeat at 0.025 sodium. percent level for 2 more days. Do not (b) Sponsors. See sponsor numbers in change litter. § 510.600(c) of this chapter: (B) As an aid in the control of acute (1) Nos. 016592, 054628, 054771, 054925, fowl cholera caused by Pasteurella and 057561 for use of the product de- multocida susceptible to sulfamerazine, scribed in paragraph (a)(1) of this sec- sulfamethazine, and sulfaquinoxaline: tion. Provide medicated water (0.04 percent (2) Nos. 054771, 054925, 057561, 058829, solution) for 2 to 3 days. If disease re- 061623, and 066104 for use of the product curs, repeat treatment. described in paragraph (a)(2) of this (ii) Limitations. Do not treat chickens section. within 14 days of slaughter for food. Do (c) Related tolerances. See § 556.640 of not medicate chickens producing eggs this chapter. for human consumption. Federal law (d) Conditions of use—(1) Broiler and restricts this drug to use by or on the replacement chickens—(i) Amount. Ad- order of a licensed veterinarian. minister 1.875 grams per gallon (0.05 (2) Turkeys—(i) Amounts and indica- percent) of drinking water for 6 con- tions for use—(A) As an aid in the con- secutive days. trol of coccidiosis caused by Eimeria (ii) Indications for use. For treatment meleagrimitis and E. adenoeides suscep- of outbreaks of coccidiosis, fowl chol- tible to sulfamerazine, sulfamethazine, era, and infectious coryza. and sulfaquinoxaline: Provide medi- (iii) Limitations. Withdraw 5 days be- cated water (0.025 percent solution) for fore slaughter. Federal law restricts 2 days, then plain water for 3 days, this drug to use by or on the order of a then medicated water (0.025 percent so- licensed veterinarian. lution) for 2 days, then plain water for (2) Turkeys—(i) Amount. Administer 3 days, then medicated water (0.025 per- 0.938 grams per gallon (0.025 percent) of cent solution) for 2 days. Repeat if nec- drinking water for 6 consecutive days. essary. Do not change litter. (ii) Indications for use. Growing tur- (B) As an aid in the control of acute keys: For treatment of disease out- fowl cholera caused by Pasteurella breaks of coccidiosis and fowl cholera. multocida susceptible to sulfamerazine, (iii) Limitations. Withdraw 5 days be- sulfamethazine, and sulfaquinoxaline: fore slaughter. Federal law restricts Provide medicated water (0.04 percent this drug to use by or on the order of a solution) for 2 to 3 days. If disease re- licensed veterinarian. curs, repeat treatment. (3) Cattle—(i) Amount. 1.18 to 2.36 (ii) Limitations. Do not treat turkeys grams per gallon (0.031 to 0.062 percent) within 14 days of slaughter for food. Do of drinking water. As a drench, admin- not medicate turkeys producing eggs ister 2.5 grams per 100 pounds of body for human consumption. Federal law weight for first day, then 1.25 grams restricts this drug to use by or on the per 100 pounds of body weight per day order of a licensed veterinarian. for the next 4 consecutive days. If no improvement within 2 to 3 days, re- [71 FR 13001, Mar. 14, 2006, as amended at 79 FR 28829, May 20, 2014; 80 FR 34278, June 16, evaluate diagnosis. Do not treat be- 2015; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, yond 5 days. Dec. 27, 2016] (ii) Indications for use. Dairy calves, dairy heifers, and beef cattle: For the § 520.2220 Sulfadimethoxine oral dos- treatment of shipping fever complex age forms. and bacterial pneumonia associated with Pasteurella spp. sensitive to § 520.2220a Sulfadimethoxine oral so- sulfadimethoxine; and calf diphtheria lution and soluble powder. and foot rot associated with (a) Specifications. (1) Each ounce of Fusobacterium necrophorum solution contains 3.75 grams (12.5 per- (Sphaerophorus necrophorus) sensitive cent) sulfadimethoxine. to sulfadimethoxine.

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(iii) Limitations. Withdraw 7 days be- § 520.2220d Sulfadimethoxine bolus. fore slaughter. A withdrawal period has (a) Specifications. Each bolus contains not been established for this product in 2.5, 5, or 15 grams sulfadimethoxine. preruminating calves. Do not use in (b) Sponsor. See No. 054771 in calves to be processed for veal. Federal § 510.600(c) of this chapter. law restricts this drug to use by or on (c) Related tolerances. See § 556.640 of the order of a licensed veterinarian. this chapter. Federal law prohibits the extralabel (d) Conditions of use in cattle—(1) use of this product in lactating dairy Amount. Administer 2.5 grams per 100 cattle. pounds body weight for 1 day followed [79 FR 28829, May 20, 2014, as amended at 81 by 1.25 grams per 100 pounds body FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, weight per day; treat for 4 to 5 days. 2016] (2) Indications for use. For the treat- ment of shipping fever complex and § 520.2220b Sulfadimethoxine suspen- bacterial pneumonia associated with sion. Pasteurella spp. sensitive to (a) Specifications. Each milliliter of sulfadimethoxine; and calf diphtheria suspension contains 50 milligrams (mg) and foot rot associated with sulfadimethoxine. Fusobacterium necrophorum sensitive to (b) Sponsors. See Nos. 000061 and sulfadimethoxine. 054771 in § 510.600(c) of this chapter. (3) Limitations. Do not administer (c) Conditions of use in dogs and cats— within 7 days of slaughter; milk that (1) Amount. Administer orally 25 mg per has been taken from animals during pound of body weight, followed by 12.5 treatment and 60 hours (5 milkings) mg per pound of body weight daily. after the latest treatment must not be used for food. A withdrawal period has (2) Indications for use. For the treat- not been established for this product in ment of sulfonamide susceptible bac- preruminating calves. Do not use in terial infections in dogs and cats and calves to be processed for veal. enteritis associated with coccidiosis in dogs. [79 FR 28829, May 20, 2014] (3) Limitations. Federal law restricts this drug to use by or on the order of a § 520.2220e Sulfadimethoxine ex- licensed veterinarian. tended-release bolus. (a) Specifications. Each extended-re- [79 FR 28829, May 20, 2014] lease bolus contains 12.5 grams sulfadimethoxine. § 520.2220c Sulfadimethoxine tablet. (b) Sponsor. See No. 054771 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 125, 250, or 500 milligrams (mg) (c) Related tolerances. See § 556.640 of sulfadimethoxine. this chapter. (b) Sponsors. See Nos. 000061 and (d) Conditions of use in beef cattle and 054771 in § 510.600(c) of this chapter. non-lactating dairy cattle—(1) Amount. (c) [Reserved] Administer one 12.5-gram-sustained-re- (d) Conditions of use in dogs and cats— lease bolus for the nearest 200 pounds (1) Amount. Administer 25 milligrams of body weight, i.e., 62.5 milligrams per (mg) per pound of body weight on the pound of body weight. Do not repeat first day followed by 12.5 milligrams treatment for 7 days. (mg) per pound of body weight per day (2) Indications for use. For the treat- until the animal is free of symptoms ment of shipping fever complex and for 48 hours. bacterial pneumonia associated with (2) Indications for use. Treatment of Pasteurella spp. sensitive to sulfadimethoxine-susceptible bacterial sulfadimethoxine; and calf diphtheria infections. and foot rot associated with Fusobacterium necrophorum sensitive to (3) Limitations. Federal law restricts sulfadimethoxine. this drug to use by or on the order of a (3) Limitations. Do not use in female licensed veterinarian. dairy cattle 20 months of age or older. [79 FR 28829, May 20, 2014] Do not administer within 12 days of

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slaughter. Federal law restricts this (ii) Indications for use. For treatment drug to use by or on the order of a li- of bacterial scours pneumonia enter- censed veterinarian. itis, bronchitis, septicemia accom- panying Salmonella choleraesuis infec- [79 FR 28830, May 20, 2014] tion. § 520.2220f Sulfadimethoxine and (iii) Limitations. Do not treat within ormetoprim tablet. 10 days of slaughter. Federal law re- stricts this drug to use by or on the (a) Specifications. Each tablet con- order of a licensed veterinarian. tains 120 milligrams (mg) (100 mg (2) Cattle—(i) Amount. For use at 2.5 sulfadimethoxine and 20 mg grams per gallon. Administer at the ormetoprim), 240 mg (200 mg rate of 1 gallon per 100 pounds of body sulfadimethoxine and 40 mg weight per day for 4 days. Use as the ormetoprim), 600 mg (500 mg sole source of sulfonamide. sulfadimethoxine and 100 mg (ii) Indications for use. For treatment ormetoprim), or 1200 mg (1000 mg of respiratory infections (pneumonia, sulfadimethoxine and 200 mg shipping fever), foot rot, calf scours; ormetoprim). and as adjunctive therapy in septi- (b) Sponsor. See No. 054771 in cemia accompanying mastitis and me- § 510.600(c) of this chapter. tritis. (c) Conditions of use in dogs—(1) (iii) Limitations. Do not treat within Amount. On the first day of treatment, 16 days of slaughter. Milk that has administer 25 mg per pound (55 mg per been taken from animals during treat- kilogram) of body weight. Then follow ment and for 72 hours (6 milkings) after with a daily dosage of 12.5 mg per latest treatment must not be used for pound (27.5 mg per kilogram) of body food. Federal law restricts this drug to weight. Do not exceed a total of 21 con- use by or on the order of a licensed vet- secutive days. erinarian. (2) Indications of use. Treatment of skin and soft tissue infections (wounds [79 FR 28830, May 20, 2014] and abscesses) in dogs caused by § 520.2240b Sulfaethoxypyridazine tab- strains of Staphylococcus aureus and lets. Escherichia coli and urinary tract infec- (a) Specifications—(1) Each tablet con- tions caused by E. coli, Staphylococcus tains 2.5 or 15 grams spp., and Proteus mirabilus susceptible sulfaethoxypyridazine. to ormetoprim-potentiated (2) Each extended-release tablet con- sulfadimethoxine. tains 5 grams sulfaethoxypyridazine. (3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 § 510.600(c) this drug to use by or on the order of a of this chapter. licensed veterinarian. (c) Related tolerances. See § 556.650 of [79 FR 28830, May 20, 2014] this chapter. (d) Conditions of use in cattle—(1) 2.5- § 520.2240 Sulfaethoxypyridazine. or 15-gram tablets—(i) Amount. Admin- ister 25 milligrams per pound of body § 520.2240a Sulfaethoxypyridazine so- weight per day for 4 days. Use as the lution. sole source of sulfonamide. (a) Specifications. Each milliliter of (ii) Indications for use. For treatment solution contains 62.5 milligrams (mg) of respiratory infections (pneumonia, sodium sulfaethoxypyridazine. shipping fever), foot rot, calf scours; as (b) Sponsor. See No. 054771 § 510.600(c) adjunctive therapy in septicemia ac- of this chapter. companying mastitis and metritis. (c) Related tolerances. See § 556.650 of (iii) Limitations. Do not treat within this chapter. 16 days of slaughter. Milk that has (d) Conditions of use—(1) Swine—(i) been taken from animals during treat- Amount. Administer 3.8 grams per gal- ment and for 72 hours (6 milkings) after lon for first day followed by 1.9 grams latest treatment must not be used for per gallon for not less than 3 days nor food. Federal law restricts this drug to more than 9 days. Use as the sole use by or on the order of a licensed vet- source of sulfonamide. erinarian.

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(2) 15-gram extended-release tablets—(i) (B) Horses. Treatment of bacterial Amount. Administer 100 milligrams per pneumonia (secondary infections asso- pound of body weight. Use as the sole ciated with Pasteurella spp.), strangles source of sulfonamide. (Streptococcus equi), and bacterial en- (ii) Indications for use. For treatment teritis (Escherichia coli). of foot rot and respiratory infections (iii) Limitations. Administer daily (shipping fever and pneumonia) caused until animal’s temperature and appear- by sulfonamide-susceptible pathogens ance are normal. If symptoms persist (E. coli, Streptococci, Staphylococci, after using for 2 or 3 days consult a Sphaerophorus necrophorus and Gram- veterinarian. Fluid intake must be ade- negative rods including Pasteurella); quate. Treatment should continue 24 to and for use prophylactically during pe- 48 hours beyond the remission of dis- riods of stress for reducing losses due ease symptoms, but not to exceed 5 to sulfonamide sensitive disease condi- consecutive days. Follow dosages care- tions. fully. Do not treat cattle within 10 (iii) Limitations. Do not treat within days of slaughter. Do not use in female 16 days of slaughter. Not for use in lac- dairy cattle 20 months of age or older. tating dairy cows. Federal law restricts Use of sulfamethazine in this class of this drug to use by or on the order of a cattle may cause milk residues. A licensed veterinarian. withdrawal period has not been estab- [79 FR 28830, May 20, 2014] lished in preruminating calves. Do not use in calves to be processed for veal. § 520.2260 Sulfamethazine oral dosage Do not use in horses intended for forms. human consumption. (b)(1) Sponsor. See No. 054771 in § 520.2260a Sulfamethazine oblet, tab- let, and bolus. § 510.600(c) of this chapter for use of 5- gram sulfamethazine bolus. (a)(1) Sponsor. See No. 016592 in (2) Related tolerances in edible prod- § 510.600(c) of this chapter for use of 2.5- ucts. See § 556.670 of this chapter. , 5-, and 15-gram sulfamethazine oblet in beef cattle, nonlactating dairy cat- (3) Conditions of use—(i) Amount. Ad- tle, and horses. See No. 061690 in minister 10 grams (2 boluses) of § 510.600(c) of this chapter for use of 5- sulfamethazine per 100 pounds of body , 15-, and 25-gram tablet in beef and weight the first day, then 5 grams (1 nonlactating dairy cattle. bolus) of sulfamethazine per 100 pounds (2) Related tolerance in edible products. of body weight daily for up to 4 addi- See § 556.670 of this chapter. tional consecutive days. (3) Conditions of use—(i) Amount. Ad- (ii) Indications for use. Ruminating minister as a single dose 100 milligrams beef and dairy calves. For treatment of of sulfamethazine per pound of body the following diseases caused by orga- weight the first day and 50 milligrams nisms susceptible to sulfamethazine: per pound of body weight on each fol- bacterial scours (colibacilloosis) caused lowing day. by E. coli; necrotic pododermatitis (foot (ii) Indications for use. For treatment rot) and calf diphtheria caused by F. of diseases caused by organisms suscep- necrophorum; bacterial pneumonia asso- tible to sulfamethazine. ciated with Pasteurella spp.; and coc- (A) Beef cattle and nonlactating dairy cidiosis caused by E. bovis and E. zurnii. cattle. Treatment of bacterial pneu- (iii) Limitations. Do not administer monia and bovine respiratory disease for more than 5 consecutive days. Do complex (shipping fever complex) not treat calves within 11 days of (Pasteurella spp.), colibacillosis (bac- slaughter. Do not use in calves to be terial scours) (Escherichia coli), necrotic slaughtered under 1 month of age or in pododermatitis (foot rot) calves being fed an all milk diet. Do (Fusobacterium necrophorum), calf diph- not use in female dairy cattle 20 theria (Fusobacterium necrophorum), months of age or older; such use may acute mastitis (Streptococcus spp.), cause drug residues in milk. Admin- acute metritis (Streptococcus spp.), coc- ister with adequate supervision. Fol- cidiosis (Eimeria bovis and Eimeria lows recomended dosages carefully. zurnii). Fluid intake must be adequate. If

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symptoms persist after 2 or 3 days, con- (iii) Limitations. If no response within sult a veterinarian. 2 to 3 days, reevaluate therapy; do not crush tablets; treated animals must [54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, 1989, as amended at 56 FR 50653, Oct. 8, 1991; not be slaughtered for food within 28 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, days after the latest treatment; Fed- 1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, eral law restricts this drug to use by or Dec. 24, 2002; 75 FR 10166, Mar. 5, 2010; 76 FR on the order of a licensed veterinarian. 17337, Mar. 29, 2011; 79 FR 28830, May 20, 2014; (c)(1) Sponsor. See No. 061623 in 81 FR 17607, Mar. 30, 2016] § 510.600(c) of this chapter for use of a 32.1-gram sustained-release bolus. § 520.2260b Sulfamethazine sustained- (2) Conditions of use—(i) Amount. 32.1 release boluses. grams (1 bolus) per 200 pounds of body (a)(1) Sponsor. See No. 000859 in weight. § 510.600(c) of this chapter for use of a (ii) Indications for use. For beef and 22.5-gram sulfamethazine prolonged-re- nonlactating dairy cattle for the treat- lease bolus. ment of diseases caused by (2) Conditions of use—(i) Amount. De- sulfamethazine-sensitive organisms as pending on the duration of therapeutic follows: bacterial pneumonia and bo- levels desired, administer boluses as a vine respiratory disease complex (ship- single dose as follows: 31⁄2 days—1 bolus ping fever complex) caused by (22.5 grams) per 200 pounds of body Pasteurella spp., colibacillosis (bac- weight; 5 days—1 bolus per 100 pounds terial scours) caused by E. coli, necrotic of body weight. pododermatitis (foot rot) and calf diph- (ii) Indications for use. Beef and non- theria caused by Fusobacterium lactating cattle for sustained treat- necrophorum, and acute mastitis and ment of shipping fever pneumonia acute metritis caused by Streptococcus caused or complicated by Pasteurella spp.) multocida; as an aid in the treatment of (iii) Limitations. After 72 hours, all foot rot, mastitis, pneumonia, metritis, animals should be reexamined for per- bacterial enteritis, calf diphtheria, and sistence of observable disease signs. If septicemia when caused or complicated signs are present, consult a veteri- by bacteria susceptible to narian. It is strongly recommended sulfamethazine. that a second dose be given to provide (iii) Limitations. Cattle that are for an additional 72 hours of therapy, acutely ill should be treated particularly in more severe cases. The parenterally with a suitable anti- dosage schedule should be used at each bacterial product to obtain immediate 72-hour interval. Animals should not therapeutic blood levels; do not slaugh- receive more than 2 doses because of ter animals for food within 16 days of the possibility of incurring residue vio- treatment; do not use in lactating lations. This drug, like all dairy cattle; Federal law restricts this sulfonamides, may cause toxic reac- drug to use by or on the order of a li- tions and irreparable injury unless ad- censed veterinarian. ministered with adequate and contin- (b)(1) Sponsor. See No. 054771 in uous supervision; follow dosages care- § 510.600(c) of this chapter for use of a fully. Fluid intake must be adequate at 27-gram sulfamethazine sustained-re- all times throughout the 3-day ther- lease bolus. apy, Do not use in female dairy cattle (2) Conditions of use—(i) Amount. 27 20 months of age or older. Use of grams (1 bolus) for each 150 pounds of sulfamethazine in this class of cattle body weight as a single dose. may cause milk residues. Do not treat (ii) Indications for use. For nonlac- animals within 12 days of slaughter. tating cattle for the treatment of in- (d)(1) Sponsor. See 000859 in § 510.600(c) fections caused by organisms sensitive of this chapter for use of a 22.5-gram to sulfamethazine such as hemorrhagic sulfamethazine sustained release bolus. septicemia (shipping fever complex), (2) Conditions of use—(i) Amount. Ad- bacterial pneumonia, foot rot, and calf minister 1 bolus (22.5 grams) per 200 diphtheria and as an aid in the control pounds of body weight, as a single dose. of bacterial diseases usually associated (ii) Indications for use. Beef and non- with shipping and handling of cattle. lactating dairy cattle for the prolonged

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treatment of the following diseases 30-gram sulfamethazine sustained-re- when caused by one or more of the list- lease bolus. ed pathogenic organisms sensitive to (2) Conditions of use—(i) Amount. Ad- sulfamethazine: bovine respiratory dis- minister at the rate of 1 bolus (30 ease complex (shipping fever complex) grams per bolus) per 200 pounds of body (Pasteurella spp.), bacterial pneumonia weight, as a single dose. (Pasteurella spp.), necrotic (ii) Indications for use. Administer pododermatitis (foot rot) orally to beef cattle and nonlactating (Fusobacterium necrophorum), dairy cattle for the treatment of the colibacillosis (bacterial scours) following diseases when caused by one (Escherichia coli), calf diphtheria or more of the listed pathogenic orga- (Fusobacterium necrophorum), acute nisms sensitive to sulfamethazine: bo- mastitis (Streptococcus spp.) and acute vine respiratory disease complex (ship- metritis (Streptococcus spp.). ping fever complex) associated with (iii) Limitations. Cattle that are Pasteurella spp.; bacterial pneumonia acutely ill should be treated by injec- associated with Pasteurell spp.; necrotic tion with a suitable antibacterial prod- pododermatitis (foot rot) and calf diph- uct to obtain immediate therapeutic theria caused by Fusobacterium blood levels; do not slaughter animals necrophorum; colibacillosis (bacterial for food within 16 days of treatment; do scours) caused by Escherichia coli; coc- not use in lactating dairy cattle; if cidiosis caused by Eimeria bovis and E. treated animals do not respond within zurnii; acute mastitis and metritis 2 to 3 days, consult a veterinarian. caused by Streptococcus spp. (e)(1) Sponsor. See No. 061623 in (iii) Limitations. For use in beef cattle § 510.600(c) of this chapter for use of an and nonlactating dairy cattle only; if 8.02-gram sulfamethazine sustained-re- symptoms persist for 2 or 3 days after lease bolus. use, consult a veterinarian; do not slaughter animals for food for at least (2) Conditions of use—(i) Amount. Ad- 8 days after the last dose; do not use in minister 2 boluses (8.02 grams per lactating dairy cattle; do not admin- bolus) per 100 pounds of body weight, as ister more than two consecutive doses. a single dose. (g) Related tolerances. See § 556.670 of (ii) Indications for use. Administer this chapter. orally to ruminating calves for the pro- (h)(1) Sponsor. See No. 000010 in longed treatment of the following dis- § 510.600(c) of this chapter for use of an eases when caused by one or more of 8.25-gram sulfamethazine sustained-re- the listed pathogenic organisms sen- lease bolus. sitive to sulfamethazine: bacterial (2) Conditions of use—(i) Amount. Ad- pneumonia (Pasteurella spp.), minister at the rate of 1 bolus (8.25 colibacillosis (bacterial scours) (E. grams per bolus) per 50 pounds of body coli), and calf diptheria (Fusobacterium weight, as a single dose. If signs of dis- necrophorum). ease are significantly reduced, it is rec- (iii) Limitations. For use in rumi- ommended that a second dose be given nating replacement calves only; 72 to provide an additional 72 hours of hours after dosing all animals should therapy. be reexamined for persistence of dis- (ii) Indications for use. Administer ease signs; if signs are present, consult orally to ruminating beef and dairy a veterinarian; do not slaughter ani- calves for treatment of the following mals for food for at least 12 days after diseases when caused by one or more of the last dose; this product has not been the listed pathogenic organisms sus- shown to be effective for nonrumi- ceptible to sulfamethazine: bacterial nating calves; exceeding two consecu- pneumonia associated with Pasteurella tive doses may cause violative tissue spp.; colibacillosis (bacterial scours) residue to remain beyond the with- caused by Escherichia coli; coccidiosis drawal time; do not use in calves under caused by Eimeria bovis and E. zurnii; 1 month of age or calves being fed an and calf diphtheria caused by all milk diet. Fusobacterium necrophorum. (f)(1) Sponsor. See No. 016592 in (iii) Limitations. Do not use in calves § 510.600(c) of this chapter for use of a to be slaughtered under 1 month of age

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or calves being fed an all milk diet. Do (d) Conditions of use—(1) Amount. Ad- not use in female dairy cattle 20 minister in drinking water to provide: months of age or older. If symptoms Cattle and swine 112.5 milligrams of persist after 3 days, consult a veteri- sulfamethazine sodium per pound of narian. Do not administer more than 2 body weight per day on the first day consecutive doses. Do not slaughter and 56.25 milligrams per pound of body animals for food for at least 8 days weight on subsequent days; Chickens, after the last dose. Do not crush bolus. 61 to 89 milligrams of sulfamethazine sodium per pound of body weight per [46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, day, and turkeys 53 to 130 milligrams 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, of sulfamethazine sodium per pound of Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR body weight per day, depending upon 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; the dosage, age, and class of chickens 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, or turkeys, ambient temperature, and 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. other factors. 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, (2) Indications for use. For treatment Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR and control of diseases caused by orga- 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, nisms sensitive to sulfamethazine. 2016] (i) Beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and § 520.2260c Sulfamethazine sustained- bovine respiratory disease complex release tablets. (shipping fever complex) (Pasteurella (a) Specifications. Each extended-re- spp.), colibacillosis (bacterial scours) lease tablet contains 8 grams (Escherichia coli), necrotic sulfamethazine. pododermatitis (foot rot) (b) Sponsor. See No. 054771 in (Fusobacterium necrophorum), calf diph- § 510.600(c) of this chapter. theria (Fusobacterium necrophorum), (c) Related tolerances. See § 556.670 of acute mastitis (Streptococcus spp.), and this chapter. acute metritis (Streptococcus spp.). (d) Conditions of use—(1) Amount. 8 (ii) Swine. Treatment of porcine grams (1 tablet) per 45 pounds of body colibacillosis (bacterial scours) weight as a single dose. (Escherichia coli), and bacterial pneu- (2) Indications for use. In calves for monia (Pasteurella spp.). sustained treatment of pneumonia (iii) Chickens and turkeys. In chickens caused by Pasteurella spp., for control of infectious coryza colibacillosis (bacterial scours) caused (Avibacterium paragallinarum), coccidi- by Escherichia coli; and calf diptheria osis (Eimeria tenella, Eimeria necatrix), caused by Fusobacterium necrophorum. acute fowl cholera (Pasteurella (3) Limitations. Treated animals must multocida), and pullorum disease not be slaughtered for food within 18 (Salmonella Pullorum). In turkeys for days after the latest treatment. Fed- control of coccidiosis (Eimeria eral law restricts this drug to use by or meleagrimitis, Eimeria adenoeides). Medi- on the order of a licensed veterinarian. cate as follows: Infectious coryza in chickens, medicate for 2 consecutive [48 FR 26763, June 10, 1983, as amended at 56 days; acute fowl cholera and pullorum FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, disease, in chickens, medicate for 6 2014] consecutive days; coccidiosis, in chick- ens and turkeys, medicate as in para- § 520.2261 Sulfamethazine sodium oral graph (c) of this section, then reduce dosage forms. amount of medication to one-half for 4 additional days. § 520.2261a Sulfamethazine solution. (3) Limitations. Add the required dose (a) Specifications. Each milliliter of to that amount of water that will be solution contains 125 milligrams (12.5 consumed in 1 day. Consumption percent) sulfamethazine sodium. should be carefully checked. Have only (b) Sponsors. See No. 016592 in medicated water available during § 510.600(c) of this chapter. treatment. Withdraw medication from (c) Related tolerances. See § 556.670 of cattle, chickens, and turkeys 10 days this chapter. prior to slaughter for food. Withdraw

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medication from swine 15 days before hours beyond the remission of disease slaughter for food. Do not medicate symptoms. Medicated chickens must chickens or turkeys producing eggs for actually consume enough medicated human consumption. Treatment of all water which provides the recommended diseases should be instituted early. dosages. Federal law restricts this drug Treatment should continue 24 to 48 to use by or on the order of a licensed hours beyond the remission of disease veterinarian. symptoms, but not to exceed a total of (2) Turkeys—(i) Amount. Administer 5 consecutive days in cattle or swine. in drinking water to provide 50 to 124 Medicated cattle, swine, chickens, and mg/lb of body weight per day turkeys must actually consume enough (ii) Indications for use. For control of medicated water which provides the coccidiosis (E. meleagrimitis, E. recommended dosages. Do not use in fe- adenoeides). male dairy cattle 20 months of age or (iii) Limitations. Add the required older. Use of sulfamethazine in this dose to that amount of water that will class of cattle may cause milk resi- be consumed in 1 day. Consumption dues. A withdrawal period has not been should be carefully checked. Have only established in preruminating calves. medicated water available during Do not use in calves to be processed for treatment. Withdraw medication 10 veal. Federal law restricts this drug to days prior to slaughter for food. Do not use by or on the order of a licensed vet- medicate turkeys producing eggs for erinarian. human consumption. Treatment of all diseases should be instituted early. [47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, Treatment should continue 24 to 48 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, hours beyond the remission of disease July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR symptoms. Medicated turkeys must ac- 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; tually consume enough medicated 81 FR 17607, Mar. 30, 2016; 81 FR 36789, June water which provides the recommended 8, 2016; 81 FR 94990, Dec. 27, 2016] dosages. Federal law restricts this drug to use by or on the order of a licensed § 520.2261b Sulfamethazine powder. veterinarian. (a) Specifications. A soluble powder (3) Swine—(i) Amount. Administer in composed of 100 percent sulfamethazine drinking water, or as a drench, to pro- sodium. vide 108 mg/lb of body weight on the (b) Sponsors. See Nos. 016592 and first day and 54 mg/lb of body weight 061623 in § 510.600(c) of this chapter. per day on the second, third, and fourth (c) Related tolerances. See § 556.670 of days of administration. this chapter. (ii) Indications for use. For treatment (d) Conditions of use—(1) Chickens—(i) of porcine colibacillosis (bacterial Amount. Administer in drinking water scours) (E. coli), and bacterial pneu- to provide 58 to 85 milligrams (mg) per monia (Pasteurella spp.). pound (/lb) of body weight per day. (iii) Limitations. Add the required (ii) Indications for use. For control of dose to that amount of water that will infectious coryza (Avibacterium be consumed in 1 day. Consumption paragallinarum), coccidiosis (Eimeria should be carefully checked. Have only tenella, E. necatrix), acute fowl cholera medicated water available during (Pasteurella multocida), and pullorum treatment. Withdraw medication 15 disease (Salmonella Pullorum). days prior to slaughter for food. Treat- (iii) Limitations. Add the required ment of all diseases should be insti- dose to that amount of water that will tuted early. Treatment should con- be consumed in 1 day. Consumption tinue 24 to 48 hours beyond the remis- should be carefully checked. Have only sion of disease symptoms, but not to medicated water available during exceed a total of 5 consecutive days. treatment. Withdraw medication 10 Medicated swine must actually con- days prior to slaughter for food. Do not sume enough medicated water which medicate chickens producing eggs for provides the recommended dosages. human consumption. Treatment of all Federal law restricts this drug to use diseases should be instituted early. by or on the order of a licensed veteri- Treatment should continue 24 to 48 narian.

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(4) Cattle—(i) Amount. Administer in per day until clinical signs are allevi- drinking water, or as a drench, to pro- ated. To reduce the possibility of re- vide 108 mg/lb of body weight on the lapse, continue therapy for a week to first day and 54 mg/lb of body weight 10 days. per day on the second, third, and fourth (2) Indications for use. For treatment days of administration. of urinary tract infections such as cys- (ii) Indications for use in beef and non- titis, nephritis, prostatitis, urethritis, lactating dairy cattle. Treatment of bac- and pyelonephritis. As an aid in the terial pneumonia and bovine res- management of complications result- piratory disease complex (shipping ing from surgical manipulations of the fever complex) (Pasteurella spp.), urinary tract such as removal of colibacillosis (bacterial scours) (E. calculi from the bladder, in coli), necrotic pododermatitis (foot rot) ureterostomies, and in instrumenta- (Fusobacterium necrophorum), calf diph- tion of the urethra and bladder. theria (F. necrophorum), acute mastitis (3) Limitations. Federal law restricts (Streptococcus spp.), and acute metritis this drug to use by or on the order of a (Streptococcus spp.) licensed veterinarian. (iii) Limitations. Add the required dose to that amount of water that will [40 FR 13838, Mar. 27, 1975, as amended at 50 be consumed in 1 day. Consumption FR 13561, Apr. 5, 1985; 79 FR 28831, May 20, should be carefully checked. Have only 2014] medicated water available during § 520.2325 Sulfaquinoxaline oral dos- treatment. Withdraw medication 10 age forms. days prior to slaughter for food. Treat- ment of all diseases should be insti- § 520.2325a Sulfaquinoxaline powder tuted early. Treatment should con- and solution. tinue 24 to 48 hours beyond the remis- (a) Sponsor. See § 510.600(c) of this sion of disease symptoms, but not to chapter for identification of the spon- exceed a total of 5 consecutive days. sors. Medicated cattle must actually con- (1) To No. 016592 for use of a 25-per- sume enough medicated water which cent sulfaquinoxaline soluble powder provides the recommended dosages. Do and a 20-percent sulfaquinoxaline so- not use in female dairy cattle 20 dium solution as provided for in para- months of age or older. Use of graph (c) of this section. sulfamethazine in this class of cattle may cause milk residues. Do not use in (2) To Nos. 016592 and 054771 for use of calves under one (1) month of age or a 31.92-percent sulfaquinoxaline solu- calves being fed an all-milk diet. Use in tion (sodium and potassium salts) as these classes of calves may cause viola- provided for in paragraphs (c)(1), (c)(2), tive residues to remain beyond the (c)(3), (c)(4)(i), and (c)(4)(ii) of this sec- withdrawal time. Federal law restricts tion. this drug to use by or on the order of a (3) No. 054771 for use of a 28.62-percent licensed veterinarian. sulfaquinoxaline sodium solution as provided in paragraphs (c)(1), (c)(2), and [71 FR 70303, Dec. 4, 2006, as amended at 75 (c)(3) of this section. FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, (b) Related tolerances. See § 556.685 of Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016] this chapter. (c) Conditions of use. It is used in § 520.2280 Sulfamethizole and methe- drinking water as follows: namine. (1) Chickens. (i) As an aid in the con- (a) Specifications. Each tablet con- trol of outbreaks of coccidiosis caused tains 250 milligrams of sulfamethizole by Eimeria tenella, E. necatrix, E. and 250 milligrams of methenamine acervulina, E. maxima, and E. brunetti. mandelate. (ii) Administer at the 0.04 percent (b) Sponsor. See No. 054771 in level for 2 or 3 days, skip 3 days then § 510.600(c) of this chapter. administer at the 0.025 percent level for (c) Conditions of use in dogs and cats— 2 more days. If bloody droppings ap- (1) Amount. Administer orally 1 tablet pear, repeat treatment at the 0.025 per- per 20 pounds of body weight 3 times cent level for 2 more days. Do not

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change litter unless absolutely nec- animal, ambient temperature, and essary. Do not give flushing mashes. other factors. A withdrawal period has (2) Turkeys. (i) As an aid in the con- not been established for trol of outbreaks of coccidiosis caused sulfaquinoxaline in preruminating by Eimeria meleagrimitis and E. calves. Do not use in calves to be proc- adenoeides. essed for veal. Not for use in lactating (ii) Administer at the 0.025 percent dairy cattle. Do not give to chickens, level for 2 days, skip 3 days, give for 2 turkeys or cattle within 10 days of days, skip 3 days and give for 2 more slaughter for food. Do not medicate days. Repeat if necessary. Do not chickens or turkeys producing eggs for change litter unless absolutely nec- human consumption. Make fresh drink- essary. Do not give flushing mashes. ing water daily. Federal law restricts (3) Chickens and turkeys. (i) As an aid this drug to use by or on the order of a in the control of acute fowl cholera licensed veterinarian. caused by Pasteurella multocida suscep- tible to sulfaquinoxaline and fowl ty- [48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 FR 29843, July 23, phoid caused by Salmonella gallinarum 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, susceptible to sulfaquinoxaline. June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR (ii) Administer at the 0.04 percent 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; level for 2 or 3 days. Move birds to 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, clean ground. If disease recurs, repeat 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, treatment. If cholera has become es- July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR tablished as the respiratory or chronic 28831, May 20, 2014; 81 FR 22523, Apr. 18, 2016; form, use feed medicated with 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 94990, Dec. 27, 2016] sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not § 520.2325b Sulfaquinoxaline drench. be kept for laying house replacements or breeders unless tests show they are (a) Specifications. A soluble powder not carriers. containing 25 percent sulfaquinoxaline. (4) Cattle and calves. (i) For the con- (b) Sponsor. See No. 016592 in trol and treatment of outbreaks of coc- § 510.600(c) of this chapter. cidiosis caused by Eimeria bovis or E. (c) Conditions of use in cattle—(1) zurnii. Amount. Administer 1 teaspoon of 25 (ii) Administer at the 0.015-percent percent sulfaquinoxaline soluble pow- level for 3 to 5 days in drinking water der for each 125 pounds of body weight medicated with sulfaquinoxaline solu- for 3 to 5 days as a drench. tion. (2) Indications for use. For the control (iii) In lieu of treatment as provided and treatment of outbreaks of coccidi- in paragraph (e)(4)(ii) of this section, osis in cattle and calves caused by administer 1 teaspoon of 25-percent Eimeria bovis or E. zuernii. sulfaquinoxaline soluble powder per (3) Limitations. Do not give to cattle day for each 125 pounds of body weight within 10 days of slaughter for food. for 3 to 5 days in drinking water. Not for use in lactating dairy cattle. (d) Limitations. May cause toxic reac- tions unless the drug is evenly mixed [79 FR 28831, May 20, 2014, as amended at 82 FR 12169, Mar. 1, 2017] in water at dosages indicated and used according to directions. For control of § 520.2330 Sulfisoxazole tablets. outbreaks of disease, medication should be initiated as soon as the diag- (a) Specifications. Each tablet con- nosis is determined. Medicated chick- tains 260 milligrams (4 grains) of ens, turkeys, cattle, and calves must sulfisoxazole. actually consume enough medicated (b) Sponsor. See No. 054771 in water which provides a recommended § 510.600(c) of this chapter. dosage of approximately 10 to 45 milli- (c) Conditions of use—(1) Amount. Ad- grams per pound per day in chickens, minister one tablet orally per 4 pounds 3.5 to 55 milligrams per pound per day of body weight. in turkeys, and approximately 6 milli- (2) Indications for use. Use in dogs and grams per pound per day in cattle and cats as an aid in treatment of bacterial calves depending on the age, class of pneumonia and bacterial enteritis

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when caused by organisms sensitive to § 520.2345b Tetracycline tablets. sulfisoxazole. (a) Specifications. Each tablet con- (3) Limitations. Repeat dosage at 24- tains 100, 250, or 500 milligrams of tet- hour intervals until 2 to 3 days after racycline (as the hydrochloride). disappearance of clinical symptoms. (b) Sponsor. See No. 054771 in (Administration of one-half daily dos- § 510.600(c) of this chapter. age at 12-hour intervals or one-third (c) Conditions of use. Dogs—(1) daily dosage at 8-hour intervals will Amount. 25 milligrams per pound of provide a more constant blood level.) body weight per day in divided doses Provide adequate supply of drinking every 6 hours. water. If symptoms persist after using (2) Indications for use. Treatment of this preparation for 2 or 3 days, consult infections caused by organisms sen- a veterinarian. sitive to tetracycline hydrochloride, [43 FR 60895, Dec. 29, 1978, as amended at 79 such as bacterial gastroenteritis due to FR 28831, May 20, 2014] E. coli and urinary tract infections due to Staphylococcus spp. and E. coli. § 520.2340 Tepoxalin. (3) Limitations. Administer orally; (a) Specifications. Each tablet con- continue treatment until symptoms of tains 30, 50, 100, or 200 milligrams (mg) the disease have subsided and tempera- tepoxalin. ture is normal for 48 hours; not for use (b) Sponsor. See No. 000061 in in animals raised for food production; § 510.600(c) of this chapter. Federal law restricts this drug to use (c) Conditions of use in dogs—(1) by or on the order of a licensed veteri- Amount. 10 mg per kilogram (/kg) daily; narian. or 20 mg/kg on the initial day of treat- [57 FR 37327, Aug. 18, 1992, as amended at 79 ment, followed by 10 mg/kg daily. FR 28831, May 20, 2014] (2) Indications for use. For the control of pain and inflammation associated § 520.2345c Tetracycline boluses. with osteoarthritis. (a) Specifications. Each bolus contains (3) Limitations. Federal law restricts 500 milligrams of tetracycline (as the this drug to use by or on the order of a hydrochloride). licensed veterinarian. (b) Sponsor. See No. 054771 in [68 FR 34795, June 11, 2003] § 510.600(c) of this chapter. (c) Related tolerances. See § 556.720 of § 520.2345 Tetracycline. this chapter. (d) Conditions of use. Calves—(1) § 520.2345a Tetracycline capsules. Amount. 10 milligrams per pound of (a) Specifications. Each capsule con- body weight per day in divided doses. tains 50, 100, 125, 250, or 500 milligrams (i) Indications for use. Control and (mg) tetracycline hydrochloride. treatment of bacterial enteritis (b) Sponsor. See No. 054771 in (scours) caused by E. coli and bacterial § 510.600(c) of this chapter. pneumonia caused by Pasteurella spp., (c) Conditions of use in dogs—(1) Hemophilus spp., and Klebsiella spp. Amount. 25 mg per pound of body (ii) Limitations. Administer orally for weight per day in divided doses every 6 3 to 5 days; do not slaughter animals hours. for food within 14 days of treatment; (2) Indications for use. For treatment use as sole source of tetracycline. of infections caused by organisms sen- (2) Amount. 10 milligrams per pound sitive to tetracycline hydrochloride, of body weight per day in two divided such as bacterial gastroenteritis due to doses. E. coli and urinary tract infections due (i) Indications for use. Treatment of to Staphylococcus spp. and E. coli. bacterial pneumonia caused by orga- (3) Limitations. Federal law restricts nisms susceptible to tetracycline, bac- this drug to use by or on the order of a terial enteritis caused by E. coli, and licensed veterinarian. salmonella organisms susceptible to [70 FR 50182, Aug. 26, 2005, as amended at 73 tetracycline. FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, (ii) Limitations. Administer orally for 2014] not more than 5 days; do not slaughter

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animals for food within 12 days of (2) Swine—(i) Amount. 10 milligrams treatment; use as sole source of tetra- per pound of body weight per day in di- cycline. vided doses. [57 FR 37328, Aug. 18, 1992, as amended at 67 (ii) Indications for use. Control and FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, treatment of bacterial enteritis 2014; 81 FR 67151, Sept. 30, 2016] (scours) caused by E. coli and bacterial pneumonia associated with Pasteurella § 520.2345d Tetracycline powder. spp., A. pleuropneumoniae (Haemophilus (a) Specifications. Each pound of pow- spp.), and Klebsiella spp., susceptible to der contains 25, 102.4, or 324 grams tet- tetracycline. racycline hydrochloride. (iii) Limitations. Administer for 3 to 5 (b) Sponsors. See sponsors listed in days; do not slaughter animals for food § 510.600(c) of this chapter for condi- within 7 days of treatment for No. tions of use as in paragraph (d) of this 066104 and within 4 days of treatment section: for Nos. 016592, 054771, 054925, 057561, (1) No. 054771: 25 grams per pound as 059130, and 061623; prepare a fresh solu- in paragraphs (d)(3) and (d)(4) of this tion daily; use as the sole source of tet- section. racycline. Federal law restricts this (2) No. 066104: 25, 102.4, and 324 grams drug to use by or on the order of a li- per pound as in paragraph (d) of this censed veterinarian. section. (3) Chickens—(i) Amount. Chronic res- (3) Nos. 016592 and 054771: 25, 102.4, and piratory disease: 400 to 800 milligrams 324 grams per pound as in paragraph (d) per gallon. Infectious synovitis: 200 to of this section. 400 milligrams per gallon. (4) Nos. 054925, 057561, 061623, and (ii) Indications for use. Control of 076475: 324 grams per pound as in para- chronic respiratory disease (CRD or graph (d) of this section. air-sac disease) caused by Mycoplasma (5) No. 016592: 25 grams per pound as gallisepticum and E. coli; control of in- in paragraphs (d)(1) and (d)(2) of this fectious synovitis caused by M. section. synoviae susceptible to tetracycline. (c) Related tolerances. See § 556.720 of (iii) Limitations. Administer for 7 to this chapter. 14 days; do not slaughter for food with- (d) Conditions of use. It is adminis- in 4 days of treatment; not for use in tered in drinking water as follows: chickens producing eggs for human (1) Calves—(i) Amount. 10 milligrams consumption; prepare a fresh solution per pound of body weight per day in di- daily; use as the sole source of tetra- vided doses. cycline. Federal law restricts this drug (ii) Indications for use. Control and to use by or on the order of a licensed treatment of bacterial enteritis veterinarian. (scours) caused by Escherichia coli and (4) Turkeys—(i) Amount. For infec- bacterial pneumonia (shipping fever tious synovitis: 400 milligrams per gal- complex) associated with Pasteurella lon. For complicating bacterial orga- spp., Actinobacillus pleuropneumoniae nisms associated with bluecomb (trans- (Haemophilus spp.), and Klebsiella spp., missible enteritis or coronaviral enter- susceptible to tetracycline. itis): 25 milligrams per pound of body (iii) Limitations. Administer for 3 to 5 weight per day. days; do not slaughter animals for food (ii) Indications for use. Control of in- within 4 days of treatment for No. fectious synovitis caused by M. 066104 and within 5 days of treatment synoviae; control of bluecomb com- for Nos. 016592, 054771, 054925, 057561, plicated by organisms sensitive to tet- 059130, and 061623; prepare a fresh solu- racycline. tion daily; use as the sole source of tet- (iii) Limitations. Administer for 7 to racycline. A withdrawal period has not 14 days; do not slaughter for food with- been established for this product in in 4 days of treatment; not for use in preruminating calves. Do not use in turkeys producing eggs for human con- calves to be processed for veal. Federal sumption; prepare a fresh solution law restricts this drug to use by or on daily; use as the sole source of tetra- the order of a licensed veterinarian. cycline. Federal law restricts this drug

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to use by or on the order of a licensed § 520.2345f Tetracycline phosphate veterinarian. complex and sodium novobiocin capsules. [59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, (a) Specifications. Each capsule con- 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, tains the equivalent of 60 milligrams of Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR tetracycline hydrochloride and 60 mil- 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; ligrams of novobiocin. 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, (b) Sponsor. No. 054771 in § 510.600(c) of Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR this chapter. 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; (c) Conditions of use in dogs—(1) 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, Amount. 10 milligrams of each anti- 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 22523, biotic per pound of body weight (1 cap- Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016] sule for each 6 pounds) every 12 hours. § 520.2345e Tetracycline solution. (2) Indications for use. Treatment of acute or chronic canine respiratory in- (a) Specifications. Each milliliter con- fections such as tonsillitis, bronchitis, tains the equivalent of either 25 or 100 and tracheobronchitis when caused by milligrams of tetracycline hydro- pathogens susceptible to tetracycline chloride. and/or novobiocin, such as Staphy- (b) Sponsor. See No. 054771 in lococcus spp. and Escherichia coli. § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (c) Conditions of use—(1) Dogs—(i) this drug to use by or on the order of a Amount. 25 milligrams per pound of licensed veterinarian. body weight per day in divided doses every 6 hours. [57 FR 37329, Aug. 18, 1992, as amended at 79 (ii) Indications for use. Treatment of FR 28831, May 20, 2014] infections caused by organisms sen- sitive to tetracycline hydrochloride, § 520.2345g Tetracycline hydrochloride such as bacterial gastroenteritis due to and sodium novobiocin tablets. Escherichia coli and urinary tract infec- (a) Specifications. Each tablet con- tions due to Staphylococcus spp. and E. tains the equivalent of 60 milligrams of coli. tetracycline hydrochloride and 60 mil- (iii) Limitations. Administer orally; ligrams of novobiocin, or 180 milli- continue treatment until symptoms grams of tetracycline hydrochloride have subsided and the temperature is and 180 milligrams of novobiocin. normal for 48 hours; not for use in ani- (b) Sponsor. See No. 054771 in mals which are raised for food produc- § 510.600(c) of this chapter. tion; Federal law restricts this drug to (c) Conditions of use in dogs—(1) use by or on the order of a licensed vet- Amount. 10 milligrams of each anti- erinarian. biotic per pound of body weight (one (2) Dogs and cats—(i) Amount. 25 milli- single-strength tablet for each 6 pounds grams per pound of body weight per or one triple-strength tablet for each 18 day in divided doses every 6 hours. pounds). (ii) Indications for use. Treatment of (2) Indications for use. Treatment of infections caused by organisms suscep- acute or chronic canine respiratory in- tible to tetracycline hydrochloride, fections such as tonsillitis, bronchitis, such as bacterial gastroenteritis due to and tracheobronchitis when caused by E. coli and urinary tract infections due pathogens susceptible to tetracycline to Staphylococcus spp. and E. coli. and/or novobiocin, such as Staphy- (iii) Limitations. Administer orally; spp. and continue treatment until the tempera- lococcus Escherichia coli. ture has been normal for 48 hours; not (3) Limitations. Federal law restricts for use in food-producing animals; Fed- this drug to use by or on the order of a eral law restricts this drug to use by or licensed veterinarian. on the order of a licensed veterinarian. [57 FR 37329, Aug. 18, 1992, as amended at 79 [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] FR 28831, May 20, 2014]

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§ 520.2345h Tetracycline hydro- moval from the intestines of the adult chloride, sodium novobiocin, and forms of the species Ancylostoma prednisolone tablets. caninum and Uncinaria stenocephala (a) Specifications. Each tablet con- (hookworms). tains the equivalent of 60 milligrams of (3) Limitations. Federal law restricts tetracycline hydrochloride, 60 milli- this drug to use by or on the order of a grams of novobiocin, and 1.5 milli- licensed veterinarian. grams of prednisolone or 180 milli- [40 FR 13838, Mar. 27, 1975, as amended at 41 grams of tetracycline hydrochloride, FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; 180 milligrams of novobiocin, and 4.5 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, milligrams of prednisolone. 1997; 79 FR 28832, May 20, 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 520.2380 Thiabendazole oral dosage (c) Conditions of use in dogs—(1) forms. Amount. 10 milligrams of each anti- § 520.2380a Thiabendazole top dress- biotic and 0.25 milligram of prednis- ing and mineral protein block. olone per pound of body weight (one (a) Conforms to N.F. single-strength tablet for each 6 pounds Specifications. XII. or one triple-strength tablet for each 18 (b) Sponsors. See sponsors in pounds) every 12 hours for 48 hours. § 510.600(c) of this chapter for use as in Treatment is to be continued with paragraph (d) of this section. novobiocin and tetracycline alone at (1) No. 051311 for use as in paragraph the same dose schedule for an addi- (d)(1)(i) of this section. tional 3 days or longer as needed. (2) No. 050604 for use as in paragraph (2) Indications for use. Treatment of (d)(1)(ii) of this section. acute and chronic canine respiratory (3) No. 012286 for use as in paragraph infections such as tonsillitis, bron- (d)(2) of this section. chitis, and tracheobronchitis when (c) Related tolerances. See § 556.730 of caused by pathogens susceptible to tet- this chapter. racycline and/or novobiocin, such as (d) Conditions of use. It is used as fol- Staphylococcus spp. and Escherichia coli, lows: when it is necessary to initially reduce (1) Horses—(i) Route of administration. the severity of associated clinical In feed, as a top dressing. signs. (a) Amount. 2 grams per 100 pounds of (3) Limitations. Federal law restricts body weight. this drug to use by or on the order of a (b) Indications for use. For control of licensed veterinarian. large strongyles, small strongyles, [57 FR 37329, Aug. 18, 1992, as amended at 79 pinworms, and threadworms (including FR 28832, May 20, 2014] members of the genera Strongylus, Cyathostomum, Cylicobrachytus, and re- § 520.2362 Thenium closylate. lated genera, Craterostomum, (a) Specifications. Each tablet con- Oesophagodontus, Poteriostomum, tains thenium closylate equivalent to Oxyuris, and Strongyloides). 500 milligrams thenium base. (c) Limitations. Add to the usual feed (a) Specifications. Thenium closylate of horses mixed into that amount of tablets contain thenium closylate the feed normally consumed at one equivalent to 500 milligrams thenium feeding. Warning: Not for use in horses as base in each tablet. intended for food. (b) Sponsor. See No. 000061 in (ii) Route of administration. In feed. § 510.600(c) of this chapter. (a) Amount. 2 grams per 100 pounds of (c) Conditions of use in dogs—(1) body weight. Amount. Dogs weighing over 10 pounds: (1) Indications for use. For control of Administer 1 tablet as a single dose. large and small strongyles, Dogs weighing 5 to 10 pounds: Adminis- Strongyloides, and pinworms of the gen- tered one-half tablet twice during a era Strongylus, Cyathostomum, single day. Repeat treatment after 2 or Cylicobrachytus and related genera, 3 weeks. Craterostomum, Oesophagodontus, (2) Indications for use. For treatment Poteriostomum, Oxyuris, and of canine ancylostomiasis by the re- Strongyloides.

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(2) Limitations. Administer in a single (i) Amount. 2 grams per 100 pounds of dosage mixed with the normal grain ra- body weight. tion given at one feeding. Warning: Not (a) Indications for use. For the control for use in horses intended for food. of infections of large strongyles (b) Amount. 4 grams per 100 pounds of (Strongylus vulgaris, Strongylus body weight. endentatus), small strongyles (1) Indications for use. For control of (Cyathastomum, Cylicobrachytus and re- ascarids of the genus Parascaris. lated genera, Craterostomum, (2) Limitations. Administer in a single Oesophagodontus, Poteriostomum), dosage mixed with the normal grain ra- pinworms (Oxyuris), and threadworms tion given at one feeding. Warning: Not (Strongyloides). for use in horses intended for food. (b) Limitations. Not for use in horses (2) Cattle—(i) Route of administration. to be slaughtered for food purposes. In feed block. When administered by stomach tube, (ii) Amount. 3.3 percent block con- for use only by or on the order of a li- sumed at the recommended level of 0.11 censed veterinarian. When for use as a pound per 100 pounds of body weight liquid oral drench or an oral paste, con- per day. sult your veterinarian for assistance in (iii) Indications for use. For control of the diagnosis, treatment, and control infections of gastrointestinal of parasitism. roundworms (Trichostrongylus, (ii) Amount. 4 grams per 100 pounds of Haemonchus, Ostertagia and Cooperia). body weight. (iv) Limitations. Administer to cattle (a) Indications for use. For control of on pasture or range accustomed to infections of ascardis (Parascaris). mineral protein block feeding for 3 (b) Limitations. Not for use in horses days. Milk taken from animals during to be slaughtered for food purposes. treatment and within 96 hours (8 When administered by stomach tube, milkings) after the latest treatment use only by or on the order of a li- must not be used for food. Do not treat censed veterinarian. When for use as a cattle within 3 days of slaughter. For a liquid oral drench or an oral paste, con- satisfactory diagnosis, a microscopic sult your veterinarian for assistance in fecal examination should be performed the diagnosis, treatment, and control by a veterinarian or diagnostic labora- of parasitism. tory prior to worming. Animals main- tained under conditions of constant (2) Pigs. As an oral paste. worm exposure may require re-treat- (i) Amount. 200 milligrams for each 5 ment within 2 to 3 weeks. Animals that to 7 pounds of body weight per dose. are severely parasitized, sick, or off (ii) Indications for use. For control of feed should be isolated and a veteri- infections with Strongyloides ransomi. narian consulted for advice concerning These infections are commonly found treatment. in Southeastern United States. (iii) Limitations. Administer to baby [40 FR 13838, Mar. 27, 1975, as amended at 41 pigs (1 to 8 weeks of age). Treatment FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, may be repeated in 5 to 7 days if nec- June 23, 2008; 79 FR 28832, May 20, 2014] essary. Before treatment, obtain an ac- curate diagnosis from a veterinarian or § 520.2380b Thiabendazole drench or diagnostic laboratory. Do not treat paste. within 30 days of slaughter. (a) Specifications. Conforms to N.F. (3) Cattle. Orally as a drench and in XII. paste form using a dosing gun designed (b) Sponsor. See No. 050604 in for the product. § 510.600(c) of this chapter. (i) Amount. 3 grams per 100 pounds of (c) Related tolerances. See § 556.730 of body weight. this chapter. (a) Indications for use. Control of in- (d) Conditions of use. It is used as fol- fections of gastrointestinal lows: roundworms (Trichostrongylus spp., (1) Horses. As a single liquid oral Haemonchus spp., Nematodirus spp., dose, administered as a drench or by Ostertagia spp., and Oesophagostomum stomach tube; or as an oral paste. radiatum).

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(b) Limitations. For most effective re- (i) Amount. 3 grams per 100 pounds of sults, severely parasitized animals or body weight. those constantly exposed to helminth (ii) Indications for use. Control of se- infection should be re-treated every 2 vere infections of gastrointestinal to 3 weeks. Milk taken from treated roundworms (Trichostrongylus spp., animals within 96 hours (8 milkings) Haemonchus spp., Ostertagia spp., after the latest treatment must not be Cooperia spp., Nematodirus spp., used for food. Do not treat cattle with- Bunostomum spp., Strongyloides spp., in 3 days of slaughter. For a satisfac- Chabertia spp., and Oesophagostomum tory diagnosis, a microscopic fecal ex- spp.). amination should be performed prior to (iii) Limitations. As a single oral dose; worming. do not treat animals within 30 days of (ii) Amount. 5 grams per 100 pounds of slaughter; milk taken from treated body weight. animals within 96 hours (8 milkings) (a) Indications for use. Control of in- after the latest treatment must not be fections of Cooperia spp. or severe infec- used for food; treatment should be re- tions of other species in paragraph peated in 2 to 3 weeks. (e)(3)(i)(a) of this section. [40 FR 13838, Mar. 27, 1975, as amended at 41 (b) Limitations. For most effective re- FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, sults, severely parasitized animals or 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, those constantly exposed to helminth May 20, 2014] infection should be re-treated every 2 to 3 weeks. Milk taken from treated § 520.2380c Thiabendazole bolus. animals within 96 hours (8 milkings) (a) Specifications. Conforms to N.F. after the latest treatment must not be XII. used for food. Do not treat cattle with- (b) Sponsor. See No. 050604 in in 3 days of slaughter. For a satisfac- § 510.600(c) of this chapter. tory diagnosis, a microscopic fecal ex- (c) Related tolerances. See § 556.730 of amination should be performed prior to this chapter. worming. (d) Conditions of use. It is used as fol- (4) Sheep and goats. Orally, as a lows: drench. (1) Cattle. In a bolus. (i) Amount. 2 grams per 100 pounds of (i) Amount. 3 grams per 100 pounds of body weight. body weight. (ii) Indications for use. Control of in- (a) Indications for use. Control of in- fections of gastrointestinal fections of gastrointestinal roundworms in sheep and goats. roundworms (general Trichostrongylus (Trichostrongylus spp., Haemonchus spp., spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., Cooperia spp., Ostertagia spp., and Oesophagostomum Nematodirus spp., Bunostomum spp., radiatum). Strongyloides spp., Chabertia spp., and (b) Limitations. As a single oral dose; Oesophagostomum spp.); also active may repeat once in 2 to 3 weeks; do not from 3 hours to 3 days following treat- treat animals within 3 days of slaugh- ment against ova and larvae passed by ter; milk taken from treated animals sheep (good activity against within 96 hours (8 milkings) after the Trichostrongylus colubriformis and axei, latest treatment must not be used for Ostertagia spp., Bunostomum spp., food. Nematodirus spp., and Strongyloides spp.; (ii) Amount. 5 grams per 100 pounds of less effective against Haemonchus body weight. contortus and Oesophagostomum spp.). (a) Indications for use. Control of se- (iii) Limitations. As a single oral dose; vere infections of gastrointestinal do not treat animals within 30 days of roundworms (genera Trichostrongylus slaughter; milk taken from treated spp., Haemonchus spp., Nematodirus spp., animals within 96 hours (8 milkings) Ostertagia spp., and Oesophagostomum after the latest treatment must not be radiatum). Control of infections with used for food; in severe infections in Cooperia spp. sheep, treatment should be repeated in (b) Limitations. As a single oral dose; 2 to 3 weeks. as a drench or bolus; may repeat once (5) Goats. Orally, as a drench. in 2 to 3 weeks; do not treat animals

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within 3 days of slaughter; milk taken (b) Sponsor. See No. 050604 in from treated animals within 96 hours (8 § 510.600(c) of this chapter. milkings) after the latest treatment (c) Conditions of use in horses—(1) must not be used for food. Amount. Administer 1 ounce of suspen- (2) Sheep and goats. In a bolus. sion per 100 pounds of body weight by (i) Amount. 2 grams per 100 pounds of stomach tube or as a drench. body weight. (2) Indications for use. For the control (ii) Indications for use. Control of in- of large strongyles, small strongyles, fections of gastrointestinal pinworms, Strongyloides and ascarids roundworms in sheep and goats (gen- (including members of the genera eral Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Strongylus spp., Cyathostomum spp., Nematodirus spp., Bunostomum spp., Cylicobrachytus spp. and related genera Strongyloides spp., Chabertia spp., and Craterostomum spp., Oesophagodontus Oesophagostomum spp.); also active spp., Poteriostomum spp., Oxyuris spp., from 3 hours to 3 days following treat- Strongyloides spp., and Parascaris spp.). ment against ova and larvae passed by (3) Limitations. Do not use in horses sheep (good activity against T. intended for human consumption. Fed- colubriformis and axei, Ostertagia spp., eral law restricts this drug to use by or Bunostomum spp., Nematodirus spp., and on the order of a licensed veterinarian. Strongyloides spp.; less effective against [40 FR 13838, Mar. 27, 1975, as amended at 62 Haemonchus contortus and FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, Oesophagostomum spp.). 2014] (iii) Limitations. As a single oral dose; do not treat animals within 30 days of § 520.2380e Thiabendazole and slaughter; milk taken from treated triclorfon. animals within 96 hours (8 milkings) after the latest treatment must not be (a) Specifications. The drug contains 5 used for food; in severe infections in grams of thiabendazole with 4.5 grams sheep, treatment should be repeated in of trichlorfon, or 20 grams of 2 to 3 weeks. thiabendazole with 18 grams of (3) Goats. In a bolus. trichlorfon. (i) Amount. 3 grams per 100 pounds of (b) Sponsor. See No. 017135 in body weight. § 510.600(c) of this chapter. (ii) Indications for use. Control of se- (c) Conditions of use in horses—(1) vere infections of gastrointestinal Amount. Administer 2 grams of roundworms (genera Trichostrongylus thiabendazole with 1.8 grams of spp., Haemonchus spp., Ostertagia spp., trichlorfon per 100 pounds of body Cooperia spp., Nematodirus spp., weight sprinkled on the animals’ usual Bunostomum spp., Strongyloides spp., daily ration of feed, or may be mixed in Chabertia spp., and Oesophagostomum 5 to 10 fluid ounces of water and admin- spp.). istered by stomach tube or drench. (iii) Limitations. As a single oral dose; (2) Indications for use. For the treat- do not treat animals within 30 days of ment and control of bots (Gasterophilus slaughter; milk taken from treated spp.), large strongyles (Strongylus spp.), animals within 96 hours (8 milkings) small strongyles (genera after the latest treatment must not be Cyathostomum, Cylicobrachytus, used for food; treatment should be re- Craterostomum, Oesophagodontus, peated in 2 to 3 weeks. Poteriostomum), pinworms (Oxyuris spp., [40 FR 13838, Mar. 27, 1975, as amended at 41 Strongyloides spp.), and ascarids FR 9149, Mar. 3, 1976; 62 FR 63271, Nov. 28, (Parascaris spp.). 1997; 79 FR 28832, May 20, 2014] (3) Limitations. Do not use in horses § 520.2380d Thiabendazole and piper- intended for human consumption. Fed- azine citrate. eral law restricts this drug to use by or (a) Specifications. Each fluid ounce of on the order of a licensed veterinarian. suspension contains 2 grams of [40 FR 23071, May 28, 1975, as amended at 48 thiabendazole and 2.5 grams of piper- FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, azine (from piperazine citrate). 2014]

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§ 520.2380f Thiabendazole and piper- (1) No. 058198 for products described azine phosphate. in paragraphs (a)(1) and (a)(2) of this (a) Specifications. Each ounce of water section. dispersible powder contains 6.67 grams (2) No. 066104 for the product de- of thiabendazole and 8.33 grams of pi- scribed in paragraph (a)(1) of this sec- perazine (as piperazine phosphate). tion. (b) Sponsor. See No. 050604 in (3) No. 054771 for the product de- § 510.600(c) of this chapter. scribed in paragraph (a)(3) of this sec- (c) Conditions of use in horses—(1) tion. Amount. 2 grams of thiabendazole and (c) Related tolerances. See § 556.732 of 2.5 grams of piperazine (0.3 ounce of this chapter. powder) per 100 pounds of body weight. (d) Conditions of use in swine—(1) Use a single oral dose. Administer as a Amounts and indications for use. Admin- drench or by stomach tube suspended ister in drinking water for 5 consecu- in 1 pint of warm water; by dose sy- tive days: ringe suspended in 1⁄2 ounce of water for (i) 3.5 mg per (/) lb of body weight each 100 pounds of body weight; or daily for treatment of swine dysentery sprinkled over a small amount of daily associated with Brachyspira feed. hyodysenteriae susceptible to tiamulin. (2) Indications for use. Treatment of (ii) 10.5 mg/lb of body weight daily for infections of large strongyles (genus treatment of swine pneumonia due to Strongylus), small strongyles (genera Actinobacillus pleuropneumoniae suscep- Cyathostomum, Cylicobrachytus, and re- tible to tiamulin. lated genera Craterostomum, (2) Limitations. Use as only source of Oesophagodontus, Poteriostomum), drinking water. Prepare fresh medi- pinworms (Oxyuris), threadworms cated water daily. Withdraw medica- (Strongyloides), and ascarids (Parascaris) tion 3 days before slaughter following in horses. treatment at 3.5 mg/lb and 7 days be- (3) Limitations. Do not use in horses fore slaughter following treatment at intended for human consumption. If 10.5 mg/lb of body weight. Swine being the label bears directions for adminis- treated with tiamulin should not have tration by stomach tube or drench, it access to feeds containing polyether shall also bear the statement ‘‘Caution: ionophores (e.g., lasalocid, monensin, Federal law restricts this drug to use narasin, salinomycin, or by or on the order of a licensed veteri- semduramycin) as adverse reactions narian.’’; if not labeled for use by stom- may occur. The effects of tiamulin on ach tube or drench, the label shall bear swine reproductive performance, preg- the statement, ‘‘Consult your veteri- nancy, and lactation have not been de- narian for assistance in the diagnosis, termined. treatment, and control of parasitism.’’ [70 FR 75017, Dec. 19, 2005, as amended at 74 [46 FR 18963, Mar. 27, 1981, as amended at 46 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, FR 52330, Oct. 27, 1981; 62 FR 63271, Nov. 28, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, 1997; 79 FR 28832, May 20, 2014] Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015]

§ 520.2455 Tiamulin. § 520.2471 Tilmicosin. (a) Specifications. (1) Each gram of (a) Specifications. Each milliliter of soluble powder contains 450 milligrams concentrate solution contains 250 milli- (mg) tiamulin hydrogen fumarate. grams (mg) tilmicosin as tilmicosin (2) Each milliliter (mL) of solution phosphate. contains 125 mg (12.5 percent) tiamulin (b) Sponsor. See No. 058198 in hydrogen fumarate. § 510.600(c) of this chapter. (3) Each mL of solution contains 123 (c) Tolerances. See § 556.735 of this mg (12.3 percent) tiamulin hydrogen fu- chapter. marate. (d) Conditions of use in swine—(1) (b) Sponsors. See sponsor numbers in Amount. Administer in drinking water § 510.600(c) of this chapter for use as in at a concentration of 200 mg per liter paragraph (d) of this section. for 5 consecutive days.

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(2) Indications for use—(i) For the con- (2) [Reserved] trol of swine respiratory disease associ- [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, ated with Pasteurella multocida and 1986, as amended at 52 FR 7832, Mar. 13, 1987] Haemophilus parasuis in groups of swine in buildings where a respiratory dis- § 520.2473b Tioxidazole paste. ease outbreak is diagnosed. (ii) For the control of swine res- (a) Specifications. Each plastic syringe piratory disease associated with Myco- contains 6.25 grams of tioxidazole. plasma hyopneumoniae in the presence (b) Sponsor. See No. 000061 in of Porcine Reproductive and Res- § 510.600(c) of this chapter. piratory Syndrome Virus (PRRSV) in (c) Conditions of use—(1) Horses—(i) groups of swine in buildings where a Amount. 5 milligrams of tioxidazole per respiratory disease outbreak is diag- pound of body weight as a single dose. nosed. (ii) Indications for use. Removal of (3) Limitations. Swine intended for mature large strongyles (Strongylus human consumption must not be edentatus, S. equinus, and S. vulgaris), slaughtered within 7 days of the last mature ascarids (Parascaris equorum), treatment with this product. Federal mature and immature (4th larval law restricts this drug to use by or on stage) pinworms (Oxyuris equi), and ma- the order of a licensed veterinarian. ture small strongyles (Triodontophorus spp.). [79 FR 18158, Apr. 1, 2014, as amended at 81 (iii) Limitations. Administer orally by FR 17608, Mar. 30, 2016; 81 FR 48702, July 26, 2016] inserting the nozzle of the syringe through the space between front and § 520.2473 Tioxidazole oral dosage back teeth and deposit the required forms. dose on the base of the tongue. Before dosing, make sure the horse’s mouth § 520.2473a Tioxidazole granules. contains no feed. Not for use in horses (a) Specifications. Each gram of gran- intended for food. The reproductive ules contains 200 milligrams of safety of tioxidazole in breeding ani- tioxidazole. mals has not been determined. Consult (b) Sponsor. See No. 000061 in your veterinarian for assistance in the § 510.600(c) of this chapter. diagnosis, treatment, and control of (c) Conditions of use—(1) Horses—(i) parasitism. It is recommended that Amount. 5 milligrams per pound of body this drug be administered with caution weight as a single dose. to sick or debilitated horses. (ii) Indications for use. Removal of (2) [Reserved] mature large strongyles (Strongylus [52 FR 43059, Nov. 9, 1987] edentatus, S. equinus, and S. vulgaris), mature ascarids (Parascaris equorum), § 520.2475 Toceranib. mature and immature (4th larval stage) pinworms (Oxyuris equi), and ma- (a) Specifications. Each tablet con- ture small strongyles (Triodontophorus tains 10, 15, or 50 milligrams (mg) spp.). toceranib as toceranib phosphate. (iii) Limitations. For administration (b) Sponsor. See No. 054771 in § 510.600 with feed: Sprinkle required amount of of this chapter. granules on a small amount of the (c) Conditions of use—(1) Dogs—(i) usual grain ration and mix. Prepare for Amount. Administer an initial dose of each horse individually. Withholding of 3.25 mg per kilogram (1.48 mg per feed or water not necessary. Not for pound) body weight, orally every other use in horses intended for food. The re- day. productive safety of tioxidazole in (ii) Indications for use. For the treat- breeding animals has not been deter- ment of Patnaik grade II or III, recur- mined. Consult your veterinarian for rent, cutaneous mast cell tumors with assistance in the diagnosis, treatment, or without regional lymph node in- and control of parasitism. It is rec- volvement. ommended that this drug be adminis- (iii) Limitations. Federal law restricts tered with caution to sick or debili- this drug to use by or on the order of a tated horses. licensed veterinarian.

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(2) [Reserved] § 520.2520 Trichlorfon oral dosage forms. [74 FR 28875, June 18, 2009, as amended at 79 FR 28832, May 20, 2014] § 520.2520a Trichlorfon and atropine. § 520.2483 Triamcinolone. (a) Specifications. (1) For trichlorfon: O,O-Dimethyl 2,2,2-trichloro-1-hydroxy- (a) Specifications. (1) Each tablet con- ethyl phosphonate. tains 0.5 milligram (mg) or 1.5 mg (2) For atropine: Atropine N.F. triamcinolone acetonide. (b) Sponsor. See No. 054771 in (2) Each 15 grams of powder contains § 510.600(c) of this chapter. 10 mg triamcinolone acetonide. (c) Conditions of use in mice—(1) (b) Sponsor. See No. 000010 in Amount. Administer 1.67 grams of § 510.600(c) of this chapter. trichlorfon and 7.7 milligrams of atro- (c) Special considerations. See § 510.410 pine per liter continuously for 7 to 14 of this chapter. days as the sole source of drinking (d) Conditions of use—(1) Dogs and water. cats. Use tablets described in paragraph (2) Indications for use. For the treat- (a)(1) of this section as follows: ment of Syphacia obvelata (pinworm) in (i) Amount. Administer 0.05 mg per laboratory mice. pound (/lb) of body weight daily by (3) Limitations. Federal law restricts mouth; up to 0.1 mg per pound (/lb) of this drug to use by or on the order of a body weight daily, if response to the licensed veterinarian. smaller dose is inadequate. Therapy [79 FR 28832, May 20, 2014] may be initiated with a single injec- tion of triamcinolone acetonide sus- § 520.2520b Trichlorfon boluses. pension as in § 522.2483 of this chapter, (a) Specifications. Each bolus contains in which case triamcinolone acetonide either 7.3, 10.9, 14.6, or 18.2 g of tablets should be administered begin- trichlorfon. ning 5 to 7 days after the injection. (b) Sponsor. See No. 054771 in (ii) Indications for use. As an anti-in- § 510.600(c) of this chapter. flammatory agent. (c) Conditions of use in horses—(1) (iii) Limitations. Federal law restricts Amount. 18.2 milligrams per pound of this drug to use by or on the order of a body weight, except for strongyles use licensed veterinarian. 36.4 milligrams per pound of body (2) Horses. Use oral powder described weight. in paragraph (a)(2) of this section as (2) Indications for use. For horses for follows: removal of bots (Gastrophilus nasalis, (i) Amount. Administer 0.005 to 0.01 Gastrophilus intestinalis), large mg/lb of body weight twice daily, sprin- strongyles (Strongylus vulgaris), small kled (top-dressed) on a small portion of strongyles, large roundworms feed. Therapy may be initiated with a (ascarids, Parascaris equorum), and single injection of triamcinolone pinworms (Oxyuris equi). acetonide suspension as in § 522.2483 of (3) Limitations. Do not use in horses intended for human consumption. Fed- this chapter, in which case eral law restricts this drug to use by or triamcinolone acetonide oral powder on the order of a licensed veterinarian. should be administered beginning 3 or 4 days after the injection. [45 FR 48127, July 18, 1980. Redesignated and (ii) Indications for use. As an anti-in- amended at 79 FR 28833, May 20, 2014] flammatory agent. § 520.2520c Trichlorfon granules. (iii) Limitations. Federal law restricts this drug to use by or on the order of a (a) Specifications. Each package con- licensed veterinarian. Do not use in tains either 18.2 or 36.4 g of trichlorfon. horses intended for human consump- (b) Sponsor. See No. 054771 in tion. § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) [75 FR 10166, Mar. 5, 2010] Amount. 18.2 milligrams per pound of body weight.

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(2) Indications for use. For horses for (b) Sponsor. See No. 043264 in § 510.600 removal of bots (Gastrophilus nasalis, of this chapter. Gastrophilus intestinalis), large (c) Conditions of use in dogs—(1) roundworms (ascarids, Parascaris Amount. The starting dose is 1.0 to 3.0 equorum), and pinworms (Oxyuris equi). milligrams per pound (2.2 to 6.7 milli- (3) Limitations. Do not use in horses grams per kilogram) once a day. intended for human consumption. Fed- (2) Indications for use. For treatment eral law restricts this drug to use by or of pituitary-dependent on the order of a licensed veterinarian. hyperadrenocorticism. For treatment [45 FR 48128, July 18, 1980. Redesignated and of hyperadrenocorticism due to amended at 79 FR 28833, May 20, 2014] adrenocortical tumor. (3) Limitations. Federal law restricts § 520.2520d Trichlorfon, this drug to use by or on the order of a phenothiazine, and piperazine dihydrochloride powder. licensed veterinarian. (a) Specifications. Each 54.10 grams [74 FR 21767, May 11, 2009, as amended at 74 (1.91 ounces) of water dispersible pow- FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, der contains 9.10 grams of trichlorfon, 2015] 6.25 grams of phenothiazine, and the equivalent of 20.0 grams of piperazine § 520.2604 Trimeprazine and prednis- olone tablets. base (as piperazine dihydrochloride). (b) Sponsor. See No. 054771 in (a) Specifications. Each tablet con- § 510.600(c) of this chapter. tains 5 milligrams (mg) trimeprazine tartrate and 2 mg prednisolone. [48 FR 2757, Jan. 21, 1983. Redesignated and amended at 79 FR 28833, May 20, 2014] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. EDITORIAL NOTE: At 79 FR 28833, May 20, (c) Conditions of use in dogs—(1) 2014, § 520.2520d was amended in part by redes- ignating paragraph (e) as (c). This action Amount. Administer orally an initial could not be performed because paragraph (e) dosage: for dogs weighing up to 10 did not exist. pounds, 1⁄2 tablet twice daily; for dogs weighing 11 to 20 pounds, 1 tablet twice § 520.2582 Triflupromazine. daily; for dogs weighing 21 to 40 (a) Specifications. Each tablet con- pounds, 2 tablets twice daily; and for tains 10 or 25 milligrams (mg) dogs weighing over 40 pounds, 3 tablets triflupromazine hydrochloride. twice daily. After 4 days, reduce dosage (b) Sponsor. See No. 054771 in to one-half the initial dose or to an § 510.600(c) of this chapter. amount sufficient to maintain remis- (c) Conditions of use in dogs and cats— sion of symptoms. (1) Amount. Administer orally 1 to 2 mg (2) Indications for use. For the relief of per pound of body weight daily, fol- itching regardless of cause; and for re- lowed by 1 mg daily. duction of inflammation commonly as- (2) Indications for use. For relief of sociated with most skin disorders of anxiety, to help control psychomotor dogs such as eczema, caused by inter- over-activity, and to increase the toler- nal disorders, otitis, and dermatitis, al- ance of animals to pain and pruritus. lergic, parasitic, pustular and nonspe- For use in various clinical procedures cific. As adjunctive therapy in various which require the aid of a tranquilizer, cough conditions including treatment antiemetic, or preanesthetic. of ‘‘kennel cough’’ or (3) Limitations. Federal law restricts tracheobronchitis, bronchitis including this drug to use by or on the order of a allergic bronchitis, in tonsillitis, acute licensed veterinarian. upper respiratory infections and [79 FR 28833, May 20, 2014] coughs of nonspecific origin. (3) Limitations. Federal law restricts § 520.2598 Trilostane. this drug to use by or on the order of a (a) Specifications. Each capsule con- licensed veterinarian. tains 5, 10, 30, 60, or 120 milligrams [79 FR 28833, May 20, 2014] (mg) trilostane.

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§ 520.2605 Trimeprazine and prednis- (b) Sponsors. See Nos. 000061 and olone capsules. 054771 in § 510.600(c) of this chapter. (a) Specifications. Each capsule con- (c) Conditions of use in dogs—(1) tains: Amount. Administer orally at 30 mg per (1) 3.75 milligrams (mg) trimeprazine kilogram of body weight (14 milligrams in sustained released form (as per pound) once daily. Alternatively, trimeprazine tartrate) and 1 mg pred- especially in severe infections, the ini- nisolone (Capsule No. 1); or tial dose may be followed by one-half (2) 7.5 mg trimeprazine in sustained the recommended daily dose every 12 release form (as trimeprazine tartrate) hours. Administer for 2 to 3 days after and 2 mg prednisolone (Capsule No. 2). symptoms have subsided. Do not treat (b) Sponsor. See No. 054771 in for more than 14 consecutive days. § 510.600(c) of this chapter. (2) Indications for use. The drug is (c) Conditions of use in dogs—(1) used in dogs where systemic anti- Amount. Administer orally once daily bacterial action against sensitive orga- an initial dosage: nisms is required, either alone or as an (i) For dogs weighing up to 10 pounds: adjunct to surgery or debridement with one Capsule No. 1; associated infection. The drug is indi- (ii) For dogs weighing 11 to 20 cated where control of bacterial infec- pounds, one Capsule No. 2 or two Cap- tion is required during the treatment sule No. 1; of acute urinary tract infections, acute (iii) For dogs weighing 21 to 40 bacterial complications of distemper, pounds, two Capsule No. 2 or four Cap- acute respiratory tract infections, sule No. 1; and acute alimentary tract infections, (iv) For dogs weighing over 40 wound infections, and abscesses. pounds, three Capsule No. 2 or six Cap- (3) Limitations. Federal law restricts sule No. 1. After 4 days, the dosage is this drug to use by or on the order of a reduced to approximately 1⁄2 the initial licensed veterinarian. dosage or to an amount just sufficient [79 FR 28833, May 20, 2014] to maintain remission of symptoms. (2) Indications for use. For the relief of § 520.2611 Trimethoprim and sulfa- itching regardless of cause; and for re- diazine paste. duction of inflammation commonly as- (a) Specifications. Each gram (g) of sociated with most skin disorders of paste contains 67 milligrams (mg) dogs such as eczema, caused by inter- trimethoprim and 333 mg sulfadiazine. nal disorders, otitis, and dermatitis, al- (b) Sponsors. See sponsors in lergic, parasitic, pustular and nonspe- § 510.600(c) of this chapter: cific. As adjunctive therapy in various (1) No. 054771 for product adminis- cough conditions including treatment tered as in paragraph (c)(1)(i) of this of ‘‘kennel cough’’ or section. tracheobronchitis, bronchitis including (2) No. 000061 for product adminis- allergic bronchitis, in tonsillitis, acute tered as in paragraph (c)(1)(ii) of this upper respiratory infections and section. coughs of nonspecific origin. (c) Conditions of use in horses—(1) (3) Limitations. Federal law restricts Amount. Administer orally as a single this drug to use by or on the order of a daily dose for 5 to 7 days: licensed veterinarian. (i) 5 g of paste (335 mg trimethoprim [79 FR 28833, May 20, 2014] and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight § 520.2610 Trimethoprim and sulfa- per day. diazine tablets. (ii) 3.75 g of paste (250 mg (a) Specifications. Each tablet con- trimethoprim and 1,250 mg sulfa- tains 30 milligrams (mg) (5 mg diazine) per 110 pounds (50 kilograms) trimethoprim and 25 mg sulfadiazine), of body weight per day. 120 mg (20 mg trimethoprim and 100 mg (2) Indications for use. For use where sulfadiazine), 480 mg (80 mg systemic antibacterial action against trimethoprim and 400 mg sulfadiazine) sensitive organisms is required during or 960 mg (160 mg trimethoprim and 800 treatment of acute strangles, res- mg sulfadiazine). piratory infections, acute urogenital

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infections, and wound infections and (iii) Limitations. Do not use in horses abscesses. intended for human consumption. Fed- (3) Limitations. Not for use in horses eral law restricts this drug to use by or intended for human consumption. Fed- on the order of a licensed veterinarian. eral law restricts this drug to use by or [78 FR 63872, Oct. 25, 2013] on the order of a licensed veterinarian. [71 FR 30802, May 31, 2006, as amended at 79 § 520.2613 Trimethoprim and sulfa- FR 28834, May 20, 2014] diazine powder. (a) Specifications. Each gram of pow- § 520.2612 Trimethoprim and sulfa- der contains 67 milligrams (mg) diazine suspension. trimethoprim and 333 mg sulfadiazine. (a) Specifications. Each milliliter (b) Sponsors. See Nos. 054771 and (mL) of suspension contains: 059051 in § 510.600(c) of this chapter. (1) 10 milligrams (mg) trimethoprim (c) Conditions of use in horses—(1) and 50 mg sulfadiazine; or Amount. Administer orally 3.75 grams (2) 400 mg combined active ingredi- of powder per 110 pounds (50 kilograms) ents (67 mg trimethoprim and 333 mg of body weight in a small amount of sulfadiazine). feed, as a single daily dose, for 5 to 7 (b) Sponsors. See sponsor numbers in days. § 510.600 of this chapter: (2) Indications for use. For control of (1) No. 000061 for use of product de- bacterial infections of horses during scribed in paragraph (a)(1) for use as in treatment of acute strangles, res- paragraph (c)(1) of this section. piratory tract infections, acute uro- (2) No. 051072 for use of product de- genital infections, wound infections, scribed in paragraph (a)(2) for use as in and abscesses. paragraph (c)(2) of this section. (3) Limitations. Do not use in horses (c) Conditions of use—(1) Dogs—(i) intended for human consumption. Fed- Amount. Administer 1 mL (10 mg eral law restricts this drug to use by or trimethoprim and 50 mg sulfadiazine) on the order of a licensed veterinarian. per 5 pounds (lb) of body weight once [58 FR 36135, July 6, 1993, as amended at 64 daily, or one-half the recommended FR 68289, Dec. 7, 1999; 79 FR 28834, May 20, daily dose every 12 hours, for up to 14 2014; 79 FR 64116, Oct. 28, 2014] consecutive days. (ii) Indications for use. The drug is § 520.2640 Tylosin. used in dogs where systemic anti- (a) Specifications. Each container of bacterial action against sensitive orga- soluble powder contains tylosin tar- nisms is required, either alone or as an trate equivalent to either 100 or 256 adjunct to surgery or debridement with grams tylosin base. associated infection. The drug is indi- (b) Sponsors—(1) No. 058198 for use as cated where control of bacterial infec- in paragraph (e) of this section. tion is required during the treatment (2) Nos. 016592 and 061623 for use as in of acute urinary tract infections, acute paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), bacterial complications of distemper, (e)(3), and (e)(4) of this section. acute respiratory tract infections, (c) Related tolerances. See § 556.740 of acute alimentary tract infections, this chapter. wound infections, and abscesses. (d) Special considerations. Federal law (iii) Limitations. Federal law restricts restricts this drug to use by or on the this drug to use by or on the order of a order of a licensed veterinarian. licensed veterinarian. (e) Conditions of use—(1) Chickens—(i) (2) Horses—(i) Amount. Administer 24 Amounts and indications for use. (A) Ad- mg combined active ingredients per minister 2 grams per gallon (528 parts kilogram of body weight (2.7 mL/100 lb) per million (ppm)) for 1 to 5 days as an twice daily for 10 days. aid in the treatment of chronic res- (ii) Indications for use. For the treat- piratory disease (CRD) associated with ment of lower respiratory tract infec- Mycoplasma gallisepticum in broiler and tions in horses caused by susceptible replacement chickens. For the control strains of Streptococcus equi subsp. of CRD associated with M. gallisepticum zooepidemicus. at time of vaccination or other stress

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in chickens. For the control of CRD as- (ii) Indications for use. For the control sociated with Mycoplasma synoviae in of American foulbrood (Paenibacillus broiler chickens. Treated chickens larvae). should consume enough medicated (iii) Limitations. The drug should be drinking water to provide 50 milli- fed early in the spring or fall and con- grams (mg) tylosin per pound of body sumed by the bees before the main weight per day. honey flow begins, to avoid contamina- (B) Administer 851 to 1,419 mg/gallon tion of production honey. Complete (225 to 375 ppm) for 5 days for the con- treatments at least 4 weeks before trol of mortality caused by necrotic en- main honey flow. teritis associated with Clostridium [40 FR 13838, Mar. 27, 1975, as amended at 50 perfringens in broiler chickens. FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, (ii) Limitations. Do not use in layers 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, producing eggs for human consump- May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR tion. Do not administer within 24 hours 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; of slaughter. 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May (2) Turkeys—(i) Amount. 2 grams per 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, gallon for 2 to 5 days as the sole source Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR of drinking water. Treated turkeys 34278, June 16, 2015; 81 FR 48702, July 26, 2016] should consume enough medicated § 520.2645 Tylvalosin. drinking water to provide 60 mg tylosin per pound of body weight per day. (a) Specifications. Granules containing (ii) Indications for use. For the reduc- 62.5 percent tylvalosin (w/w) as tion in severity of effects of infectious tylvalosin tartrate. sinusitis associated with Mycoplasma (b) Sponsor. See No. 066916 in gallisepticum. § 510.600(c) of this chapter. (iii) Limitations. Do not use in layers (c) Related tolerances. See § 556.748 of producing eggs for human consump- this chapter. tion. Do not administer within 5 days (d) Conditions of use in swine—(1) of slaughter. Amount. Administer 50 parts per mil- (3) Swine—(i) Amount. 250 mg per gal- lion tylvalosin in drinking water for 5 lon as the only source of drinking consecutive days. water for 3 to 10 days, depending on the (2) Indications for use. For the control severity of the condition being treated. of porcine proliferative enteropathy (ii) Indications for use. (A) For the (PPE) associated with Lawsonia treatment and control of swine dys- intracellularis infection in groups of entery associated with Brachyspira swine in buildings experiencing an out- hyodysenteriae when followed imme- break of PPE. diately by tylosin phosphate medicated (3) Limitations. Federal law restricts feed; and for the control of porcine pro- this drug to use by or on the order of a liferative enteropathies (PPE, ileitis) licensed veterinarian. associated with Lawsonia intracellularis [77 FR 55415, Sept. 10, 2012] when followed immediately by tylosin phosphate medicated feed. PART 522—IMPLANTATION OR (B) For the treatment and control of INJECTABLE DOSAGE FORM NEW swine dysentery associated with ANIMAL DRUGS Brachyspira hyodysenteriae. (iii) Limitations. Do not administer Sec. within 48 hours of slaughter. As indi- 522.23 Acepromazine. cated in paragraph (d)(3)(ii)(A) of this 522.52 Alfaxalone. section, follow with tylosin phosphate 522.56 Amikacin. medicated feed as in § 558.625(f)(1)(vi)(c) 522.62 Aminopentamide. of this chapter. 522.82 Aminopropazine. (4) Honey bees—(i) Amount. Mix 200 522.84 Beta-aminopropionitrile. milligrams tylosin in 20 grams confec- 522.88 Amoxicillin. 522.90 Ampicillin injectable dosage forms. tioners’/powdered sugar. Use imme- 522.90a Ampicillin trihydrate suspension. diately. Apply (dust) this mixture over 522.90b Ampicillin trihydrate powder for in- the top bars of the brood chamber once jection. weekly for 3 weeks. 522.90c Ampicillin sodium.

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